chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, facility has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
diarrhea, body ache, cramps, weakness, headache, large swelling @ inj;
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. No medical history or concurrent condition were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, vial 19400 PFU (lot number, dose, frequency and route of administration not provided). Co-suspect or concomitant therapies were not reported. On an unknown date, the patient received ZOSTAVAX and later developed shingles. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
A nurse reported that an adult male received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 12/29/99. The pt subsequently, developed welts with itching on his chest and his hands extending to his elbows. He was treated with prednisone and diphenhydramine. The welts and itching persisted as of 3/13/00.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 25th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, muscle pain and activities of daily living impaired. The patient was treated with ADVIL. On an unknown date, the outcome of the general body pain, muscle pain and activities of daily living impaired were unknown. It was unknown if the reporter considered the general body pain, muscle pain and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that the patient experienced sudden onset of total body aches and muscle pain from head to legs, sufficient to cancel her planned day's activities. The patient self-medicated with ADVIL and reported no relief.
Patient states her arm was slightly uncomfortable for 2 days after vaccine ration. Then discomfort resolved. On 2/9/05 she noticed a deep ache in her left arm just above her elbow up to near the injection site slightly radiating to back of the arm. Now she feels discomfort has radiated to back near axilla improving.
Baseball-sized area of redness and erythema at left thigh injection site X 48 hours; inconsolable crying and fussiness X over 8 hours, following injection.
The patient called on 11/05/2021 stating that she has adverse reaction to her second dose of Pfizer vaccine and wanted to report it. She had her second dose on 10/29/2021. She states that on 11/2 she had pain under her shoulder blade and that pain was spreading from one shoulder to another. She used heat pad for 2 days and the pain went away. Now she has headache ,cough and a lot of mucus and she thinks that it is a side effect of Pfizer vaccine. She does not have PCP at this time. I asked her to stay rested, hydrated ,check  fever and recommended to get OTC products to treat the symptoms
5-10 minutes post vaccination patient began not feeling well, had near syncope episode. Patient was monitored for 30 minutes - symptoms fully resolved and discharged home with mother.
PROSTRATION  3 DAYS  RECOVERED--SYMPTOMATIC TREATMENT; FATIGUE 3 DAYS  RECOVERED--SYMPTOMATIC TREATMENT; MYALGIAS  3 DAYS  RECOVERED-- SYMPTOMATIC TREATMENT; ARTHRALGIAS. 3 DAYS  RECOVERED --SYMPTOMATIC TREATMENT; HA. 3 DAYS  RECOVERED--SYMPTOMATIC TREATMENT.
We are not sure if this is the exact date that symptoms first occurred, as daughter didn't tell us right away.  Started with a headache which worsened as the days went on. She started experiencing confusion and forgetfulness of tasks that she could do before. She forgot how to do a simple x y graph. Read notes incorrectly during a concert; which she had been playing for at least 2 months. Couldn't figure out how to change the channels on a tv remote.  Couldn't open a small carton of milk.  Nor could she count backwards from 100 by sevens.  This is a student who takes all honors classes and is ranked 22 out of 485 in her class.  We took her to the local ER where they started an IV an gave her Trdal, Reglan, and Benadryl with some relief of headache and was discharged. 3/8/2012 ER then admitted.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
vague parental description-pt w/known sz DO on PB, level is pending; pt vax w/DT 15FEB95 1130AM- 2PM to ER w/heavy breathing, sweating & shaking different from when had sz; ER MD gave APAP for 100.4 R temp & sent home w/no labs:
Immediately after shot I felt a slightly elevated heart beat and 5 minutes later I blacked out and tensed up according to a witness. My back was also sore from whatever happened while unconscious. I never had an adverse effect with a vaccine before. After I came around I felt tingling in my arms and hands for 5-10 minutes. Back pain subsided shortly after. No other side effects
Within seconds, heart racing, headache, shooting tingling down arm and leg, tingling all over, couldn't walk. Lasted at least until got home. Slept for 1-2 days.
Shortly after receiving the vaccine, patient started to feel a warm sensation start from her feet and move up her legs up her boday and she started to feel flushed and lightheaded, and was warm and had a tingling feeling in her throat. She denied any feelings of SOB or that her throat was getting thick or that she could not swallow, her lungs were CTA. She was removed from the vaccine cell and taken to the observation area. Vital signs on arrival were 176/110, she was placed on a litter and history obtained. She was assessed and continued to be observed with sequential vital signs. She denied any tunnel vision, and nausea or any bowel or bladder urgency. Her f/u vital signs were 132/95, HR 85, and 100% O2 on room air. Patient was given water, and was observed for a total of 40 minutes. Final vital signs were 108/72. Patient stated that her symptoms resolved, her cheeks were flushed, her throat tingling was gone, and she stated that she felt better. Patient was able to ambulate off of the site.
Headaches for one week after vaccine, fatigue, moderate joint and muscle pain, swelling of lymph nodes under arms.
CLIENT DEVELOPED GENERALISED BODY RASHES 24 HOURS AFTER THE VACCINATION AS PER THE CLIENT.HE HAS SOME RASHES ON HIS BACK TODAY WHEN HE CAME FOR HIS OTHER VACCINATION. HE NEVER REPORTED TO ANY DOCTORS
I ended up with Covid, was hospitalized and am now home recovering.  Started with feeling of a cold, moved to my chest quickly.  Headache, no taste, no smell, fever, aches.  Everything is back to normal except still on oxygen and having trouble with that.
Dizziness, Headache, Palpitations, HYPERtension, anxiety and stated SOB Narrative:
Chills, muscle aches, headache, dizziness/lightheaded upon standing all lasting for 2.5 days. Took Tylenol for the headache and muscle aches.
5p on 10/24/02 awoke from nap with nausea, low grade fever 99.6 degrees and diarrhea. All fingertips reddened, itchy, swollen around nail bed to 1/3 up finger. Swollen red itchy around nailbeds fingers. 10/29/02 all better. Clinical follow up 10/24 and 10/29/02.
Cough; Sore Body; Slight Fever; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough), PAIN (Sore Body) and PYREXIA (Slight Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L030821A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COUGH (Cough), PAIN (Sore Body) and PYREXIA (Slight Fever). At the time of the report, COUGH (Cough), PAIN (Sore Body) and PYREXIA (Slight Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.  The patient got a Covid Test (results unknown)  As stated by the patient she was fine now.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Event outcome updated. Reporter declined further follow-up.
"Covid arm" - large welt, maybe 2-3 inches in diameter, hard in the center, mildly painful, mildly itchy for a day or two.  One week later it is almost entirely gone.
Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022 at 6:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  On 21-Jan-2022 vial was initially stored in the refrigerator and administered on 21-Feb-2022 at 06:00 am.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up contains Patient details and date and lot numbers of first and second doses were added.
Patient called to report that he felt chest tightness difficulty breathing, he could not mover and could not close his eye. He did not seek medical attention. At the time of the call, he only had a sore throat and arm pain. Advised that he go see his doctor right away. He called the day after he had the symptoms (8/13/16).
This case was reported by a healthcare professional, an occupational health nurse, and described the occurrence of swelling injection site in a 50-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 15 April 2009 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown left arm). On 15 April 2009, than one day after vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site redness in the left arm. On an unspecified date, the subject sought medical attention by calling the nurse practioner on duty at occupation health. At the time of reporting the events were unresolved. Follow-up information received on 27 May 2009 indicated that the events began on 15 April 2009 and resolved by 07 May 2009. In the reporter's opinion, the events were considered to be related to treatment with BOOSTRIX.
Got shingles from the vaccine/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles from the vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles from the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. According to narrative verbatim the causality was conservatively captured as possible. Follow-up would not possible as no contact details were available.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 18-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006463:
This initial spontaneous case was received from other-non-health professional on 11-Oct-2017, concerning a 42-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date and month of 2015, the patient was administered with influenza vaccine (dose, batch number, manufacturer, trade name, route of administration, anatomical location: not reported). On an unspecified date and month of 2015, after the vaccination, the patient felt unwell with aches and low-grade fever for couple of days. It was reported that, the patient did not want to receive another flu shot. On an unspecified date and month of 2015, the patient was recovered from the events. The reporter assessed the report as non-serious. Significant case correction received 11-Oct-2017: The causality of the events was corrected to related from unassessable.
Tinnitus - developed on 1/5 in the morning, constant ringing in his ears. Went to dr. on 1/6 and he did an irrigation of the ears with no relief.
At time of second vaccination, client reported that for several months following vaccination (initial start of symtoms unknown), reported intermittent red and itchy bumps, approximately 5mm in diameter, down same limb as vaccine and then on various spots across body. Client indicated this lasted up until 3 weeks before receiving second vaccine on 9/10/18.
Soreness at injection site lasting several days on 1st shot, still sore on second dose, 2nd dose 36 hours of flu like symptoms.
Pt recvd 3 doses of Engerix-B 1NOV90, 26NOV90, & 2MAY91 & 10SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Pt developed small blisters at site of injection (varicella SQ). Advise parent to give BENADRYL and MOTRIN or TYLENOL as needed & to apply cool compress on & off. To also seek medical tx at dr or ER if s/s worsen.
Patient inadvertently received 3rd dose of COVID-19 vaccination. He had received 1 dose of Pfizer COVID-19 vaccination on 6/21/21 prior to facility admission. He received what was thought to be 1st dose of COVID-19 vaccination on 10/19/21. Following administration of what was thought to be 2nd dose on 11/19/21, it was discovered that he had 1 dose prior to  admission.  The 3rd vaccination resulted in mild fever 100.1, erythema & swelling at injection site, shakiness, weakness, fatigue, slowness with mobility & verbalizations starting about 12-18 hours after vaccination, but systemic effects resolved in 24-36 hours.
Hospitalized for lower extremity weakness 21 days after positive COVID PCR. Concerns for Guillain-Barre.
5 month old child getting the Fluzone Quadrivalent 0.5 mL injection, no AE; Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a five months old male patient who was vaccinated with a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6695MA, expiry date: 30-June-2020 via unknown route in unknown administration site on 17-Dec-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 inappropriate age at vaccine administration. It was reported that a five month old child getting the Fluzone Quadrivalent 0.5 mL injection due to the parents ordering the vaccine and the office being kind of busy and not realize the age.  At the time of reporting, no adverse event was 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 and Module VI of the 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.
cold sores; lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow; muscle soreness; joint pain; fever, 101.5°F, very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sores), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sores), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse reaction, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sores), LYMPHADENOPATHY (lymph nodes ere swollen and painful, lymph nodes in throat were swollen as well, so it was painful to swallow), MYALGIA (muscle soreness), ARTHRALGIA (joint pain) and PYREXIA (fever, 101.5°F, very low grade fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Rheumatologist recommended to stop taking biologicals when getting the vaccine.   This case was linked to MOD-2021-390501, MOD-2021-390502 (Patient Link).