chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022).    Concomitant medications details were not reported by the reporter. It was reported that 10 days past expiry date the patient received the vaccine. Vial was initially stored in refrigerator on  07-JUN-2022. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursion. Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681156 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681156:Master case
30 seconds to 1 minute after receiving vaccine, client lost consciousness, and became pale. The client then became flushed and started jerking (arms and legs) for about ten seconds. Client regained consciousness and stated that his mouth felt dry and heart was racing. SAO2 97%, HR 40, BP low. After rebreathing into a  paper bag, patient stated he felt "fine".
Tdap given (L) delt at 2:15 pm. At 6 pm pt noticed dime size redness/swelling. 9am 4/19/11 redness/swelling increased in size, warm to touch. On 4/20/11 redness/swelling 5.5 cm in length and 3 cm width, still warm to touch. Pt has been taking Ibuprofen/BENADRYL and applying cool compress.
Patient came to get her second dose of Moderna vaccine. I logged everything in the ipad as Moderna. I then walked her back to lab 2 and drew 0.3 mL of Pfizer and gave her the vaccine in the L arm. I did not realize my mistake until I was documenting on the vial log. I spoke with nursing supervisor who consulted with for guidance. I also spoke with the our medical director about the incident. We informed patient of occurrence, gave her the chance to ask questions and let her know that she would not need an additional dose of the vaccine at this time. After waiting 15 minutes that patient said she felt fine and left.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 57 years old male patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI994AB and expiry date: 09-Apr-2019) via intramuscular route in the left deltoid (dose in series not reported) on 18-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a 57 years old patient received the following vaccination. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
weak for a couple of days; start throwing up within 4 to 6 hours and can't quit until everything is up including blood; Initial information regarding this unsolicited valid non-serious social media case reported by consumer (patient) and transmitted to Sanofi on 16-Dec-2020.  This case involves an unknown age patient who was weak for a couple of days (Asthenia) and start throwing up within 4 to 6 hours and cannot quit until everything is up including blood (vomiting), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications 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 on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who was weak for a couple of days (Asthenia) and start throwing up within 4 to 6 hours and cannot quit until everything is up including blood (vomiting) was reported.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There would be no information available on batch number for this case.
This case was reported by a physician via call center representative and described the occurrence of lethargy in a 63-year-old male patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. The patient's past medical history included allergic to dogs. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (received In 1971, and had a reaction to an unknown influenza vaccine which required hospitalization for two days). Additional patient notes included none. On 10th August 2010, the patient received Flu trivalent vaccine. On 10th August 2010, less than a day after receiving Flu trivalent vaccine, the patient experienced lethargy, weakness, decreased white cell count and liver function test abnormal. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the lethargy, weakness, decreased white cell count and liver function test abnormal were recovered/resolved. It was unknown if the reporter considered the lethargy, weakness, decreased white cell count and liver function test abnormal to be related to Flu trivalent vaccine. Additional details were reported as follows: This case was reported by the patient who himself was a physician. The age at vaccination was not reported, however it could be 62 or 63. On 10th August 2010, the patient experienced lethargy and weakness. The patient had blood work two days after the Flu trivalent vaccine, and his AST (aspartate aminotransferase) levels were 38 and his ALT (alanine aminotransferase) was at 72. The patient's WBC (white blood cells) was down to 2.3. The patient had recovered and did not have a flu shot since.
Patient developed urticaria & eye swelling 24 hours following vaccines. Patient also has history of recurrent urticaria to unidentified allergen has been referred to an allergist. Patient was also exposed to new family cat and dog during same time frame & ha: continued to develop urticaria incontinently.
2 days p/vax pt devel large tender axillary lymph node;3 days p/vax maculopapular rash; mos prominant on lt arm;
high cholesterol; dizziness; couldnt even stand up; very tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "sensitive to all kinds of medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; DYSSTASIA (non-serious), outcome "unknown", described as "couldnt even stand up"; FATIGUE (non-serious), outcome "unknown", described as "very tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient wants to know how much cholesterol the Pfizer BioNTech Covid-19 vaccine has, and reporter stated each dose of COMIRNATY contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each 0.3 mL dose of the COMIRNATY also includes the following ingredients: lipids (0.43 mg) ((4-hydroxybutyl) azanediyl) bis(hexane-6,1-diyl) bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. This consumer is the patient who called with questions regarding the Pfizer Covid-19 Vaccine booster dose which she has not been administered. She reported having been administered 2 doses of Pfizer Covid-19 Vaccine.  She has had what is considered a severe reaction from both the first and second doses of Pfizer Covid-19 Vaccine. Because she did get a little up and above reactions to the first and second doses of Pfizer Covid-19 Vaccine; and she is really sensitive to all kinds of medications; she wanted some information on the Pfizer Covid-19 Vaccine booster dose. She asked if you could tell by the Lot number which type of Pfizer Covid-19 Vaccine she was administered for the first and second doses. She is reading now that there are several different types that you can get of the Pfizer Covid-19 Vaccine, she asked if that is correct; if there are different types of Pfizer Covid-19 Vaccine; or if the Pfizer Covid-19 Vaccine Booster is a different type of Pfizer Covid-19 Vaccine or the same type that she got of her first and second doses of Pfizer Covid-19 Vaccine because she does not know what type of Pfizer Covid-19 Vaccine she got for the first and second doses.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Changes in menstruation within 2 hours of 1st dose on 8/10/21. Cycle started 5 days early, went off after 4 days, and came back on the next week for 2 days. Headache on and off.  Most severe headache for 2 days after both vaccines. Lower back pain for 3 days with 1st dose. Heart palpitations on and off with both doses.   1st dose-8/10/2021 2nd dose-8/31/2021
Ten minutes after vaccine became dizzy, diaphoretic, tachycardiac and hypertensive.  Felt better went home started vomiting With dizziness. Went to ER. Admitted for 3 days. Still suffering from dizziness and under care of ENT doctor being treated now for BPPV
Arm started feeling warm 5/11/17. Patient notice blister, soreness, and itching 5/12/17. 1 cm blister, darker red circle around blister measures 4 cm. 20 cm x 17 cm swelling and redness. BENADRYL for itching and AUGMENTIN 875 mg BID for 7 days.
Information has been received from an RN concerning an 43 year old female with no medical hx or allergies who on 30OCT2003 was vaccinated with a first dose of pneumococcal 23 v polysaccharide vaccine. Concomitant vaccination in "the other arm" included a dose of influenza virus vaccine. There was no other concomitant medication. The reporter indicated that the pt developed a reddened area around the injection site with edema. No treatment was required for the event. The reporter also noted that she was concerned abut the lot number and has pulled the remaining vials in this lot form the stock.  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that two other female pts had similar rxns after therapy with pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Middle of February, I started having abominable pain with some nausea. Worse in the morning. I went to ER and they did some testing. Pain meds and medication for nausea and Lidocaine patches. Went to - Dr put me on Prilosec at the begging of March. Pain continued. I had an endoscopy on 4/6/2021 and it showed the beginnings of two ulcers and irritation of lining. They took me off Prilosec and put me on Protonix. I followed up with doctor in the middle of May and I was doing better and they reduced it to half a Protonix dose and symptoms have come into control. No caffeine, alcohol and spicy foods - so I've had some dietary changes. I had a duodenal ulcer in my 20's that presented pretty much with the same symptoms. Still on my other meds.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    No concomitant medications were reported. The age of the patient was reported as over 65 years. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse vent were unknown.  The vaccine was administered in the deltoid site. On 11-May-2023, 26 patient's were contacted, and on 12-May-2023 18 patient's received an additional 0.25ml.  No treatment medications were reported.  This case contains information for the 6th of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Larger welt at injection site (left arm). Approx 2 inches in diameter. Faint rash that itches (almost like pimples) on forearms. All symptoms occurred the day after immunization.
This spontaneous report was received from a pharmacist concerning a 67 year old male patient. Patient current conditions included gastroesophageal reflux disease (GERD), anxiety, insomnia, high blood pressure and high cholesterol. On 25-SEP-2012, the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscularly (lot number: 669579/0595AA, expiry date: 30-AUG-2012). Thirty minutes later (on 25-SEP-2012), he received another dose of PNEUMOVAX23 intramuscularly. Lot number and expiry date was provided as H010515 and 13-FEB-2014 respectively. Concomitant medications included omeprazole, diazepam, zolpidem tartrate, CRESTOR and lisinopril. On 25-SEP-2012 (that night), the patient became tired, felt feverish and experienced a red, swollen area at the injection site. The patient came back to the pharmacy. He took TYLENOL as a treatment. The outcome of felt feverish, red, swollen area at the injection site and tired was reported as not resolved at the time of reporting. The relatedness for tired, red, swollen area at the injection site and felt feverish was unknown for PNEUMOVAX23. Additional information has been requested.
Patient began developing oral ulcers.  She had recurrent oral ulcers throughout the fall and in December 2015 was diagnosed with autoimmune neutropenia.
Information has been received from a registered nurse concerning a 22 month old female with a peanut allergy who on 16-SEP-2005, was vaccinated SC with a first dose of Varivax (Oka/Merck) (lot# 649270/0987P). Concomitant vaccination included a first dose of FLUZONE (lot# U1743JA) IM and a fourth dose of PREVNAR (lot# A56H7F) IM. There was no illness at the time of vaccination. On approximately 14-JUL-2006 the patient developed bilateral otitis media and an upper respiratory tract infection which were treated with AUGMENTIN ES-600 bid for 10 days, with improvement. On 18-JUL-2006 the patient developed a breakthrough rash described as vesicles filled with clear fluid on her left arm, left leg, and face. On 20-JUL-2006 the patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was diagnosed with a possible mild varicella. Supportive care was provided. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
pt recv vax 1MAy96 & 1MAY95 pt exp sl fever & sore arm x 2 days;3MAY95 pt completely recovered;
Seen on 7/21/06 for cellulitis right leg had redness for 2 weeks, RX Keflex 250/5 3cc po Bid x 10 days.
Nausea; Vomiting; Lost weight; Diarrhea 5-8 times a day; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 19Apr2021 at 14:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced nausea, vomiting, lost weight and had one week of diarrhea 5-8 times a day. The patient was on day 12 at the time of report and still had nausea and vomiting, lost weight. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021 post vaccination, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event had one week of diarrhea 5-8 times a day was resolved on an unknown date in Apr2021. The clinical outcome of the events nausea, vomiting and lost weight was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Only one arm was sore for a day; This is a spontaneous report from a contactable consumer reported for herself.   A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (reported as 3:00 o clock) (Batch/Lot Number: ER8732) as single dose for covid-19 immunisation.  Medical history included blood pressure high, osteoarthritis and fibromyalgia from an unknown date and ongoing. Concomitant medications included amlodipine taken for blood pressure high from an unspecified start date and ongoing; meloxicam taken for osteoarthritis, fibromyalgia from an unspecified start date and ongoing. Historical Vaccine included Flu shot and experienced sore. There were no additional vaccines administered on same date of the Pfizer suspect and no Prior Vaccinations within 4 weeks. The patient stated with the first vaccine, only one arm was sore for a day. But overall she was okay. The outcome of event was recovered on an unspecified date.    No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jul2021 at 12:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypothyroidism from an unknown date and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fluticasone propionate; salmeterol xinafoate (ADVAIR); both for an unknown date for an unknown indication and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jul2021 at 15:45, the patient experienced tingling in extremities, lesions on tongue and throat. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with steroid, Benadryl and Pepcid IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in extremities, lesions on tongue and throat was recovering at the time of this report.
Patient c\o itchiness to palms and scalp. Patient given Benadryl 25mg po as ordered per standing orders for itchiness. Patient's symptoms resolved prior to discharge.
pt has hx. of fainting with blood draw. at charting area pt c/o feeling weak & dizzy No LOC