chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) 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 (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    Concomitant product use was not provided by the reporter.  Vial size was reported as 10 dose vial.  The vial was initially stored in the refrigerator on 14-Mar-2023   The vial did not undergo any temperature excursions.  She had expired vaccine that was administered on 15-Mar-2023 there was between 75 and 125 people that was vaccinated and then on 03-Mar-2023 there was others vaccinated she do not have a number yet on who was vaccinated. Vaccine was expired on 26-Feb-2023 and 28-Feb-2023.   HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 people on 15-Mar-2023.   There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at this time.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
03dec08 Pt received vaccine, Had Hard lump and pain in area got worse around 20:00. 05dec08 Area of lump around 60mm Pt had extreme pain in area, tenderness, swelling, and itching. 10dec08 pt noticed rash extreme itching area was red swelling and warm to the touch small amount of streaking. Area was about 60mm.
Developed shingles 4 days after receiving flu vaccination. Placed on ZOVIRAX.
The vaccinee received her first injections of Twinrix on 03/20/02. On 03/21/02, one day post-immunization, the vaccinee  experienced chills and flu-like symptoms. These events persisted as of 03/22/02 The vaccine provider considered the events to be possibly related to Twinrix administration.
Difficulty swallowing and left sided throat swelling after having covid vaccine almost immediately after receiving vaccine. Patient was given Benadryl and sent to ER. Patient has improved and being discharged.
rash; sinus infection; got her first shot on 10/23/2019 and she plans on postponing her second dose (due to the Covid 19 pandemic situation; This case was reported by a nurse via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in an unknown date).   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced rash, sinus infection and social problem. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the rash and sinus infection were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the rash and sinus infection to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient got her first shot on 23rd October 2019, and she plans on postponing her second dose due to the Covid 19 pandemic situation.   The patient was planning on getting the second shot of the series a few weeks ago but did not because she had a sinus infection.  The patient  had recovered from the sinus infection. She took antibiotics to treat it.   On 23rd October after vaccination with Shingrix and Influenza vaccine Quadrivalent 2019-2020 season developed a rash on the same arm where the Shingrix was injected. The rash was not at the injection site (deltoid) but it was down by her elbow. The patient consented to follow up. This case is 1 out of 3 cases reported by the same reporter.
Started becoming very warm while resting in bed getting ready for sleep. Fell asleep and woke up a little while later sweating from head to toe and trembling. Thinking was hard, but not actually confused. I thought maybe I needed to eat something because occasionally I have low blood sugars (not diagnosed) and get sweaty and nauseated. I wasn't nauseated but thought I'd try to eat something anyway but couldn't. The mental fog was very disconcerting. I don't know how long the sweat lasted but probably not more than 5 minutes. When it started abating, I laid down again and fell asleep. I didn't have any after effects when I woke up again. This may have nothing to do with the vaccination of course.
At approx. 1126 patient c/o tingling and coldness in left arm.  BP 126/85, P-82, R-20, SpO2 98%. At approx. 1140 pt. reports symptoms have gone.  BP 109/78, P 83, R 20, SpO2 98%.
Half hour after injection broke into cold sweat for approx 45 minutes. Then between 6-6:30 pm baseball size knot surrounding injection site. The arm went numb and numbness remained for 1.5 days. Took Benadryl at 7:15 pm and swelling gone by next morning. Only able to lift arm over head after 2 days.
Pain in my left deltoid for 1 month after receiving the vaccine. I thought it would go away but it has not.
Swelling at the injection site; Pain under the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Pain under the injection arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Pain under the injection arm). At the time of the report, INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Pain under the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She had a sore throat, and then she got really tired. It just progressed. I took her to her pediatrician's office because I thought she had strep throat, but it was negative. She also had a fever, and I gave her Tylenol for it. It took about 3 or 4 days for her to feel better.
On oxygen had major congestion for 3 weeks has subsided; Since the vaccine it will not go down under 250 stays there to 300 with same insulin requirements; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 10May2021 11:00 AM (At the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history included oxygen insulin COPD (chronic obstructive pulmonary disease). The patient had known allergies to Amoxicillan. Concomitant medications included Insulin, metformin, furosemide, lisinopril and atorvastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. On 11May2021 at 07:00 AM, the patient experienced on oxygen had major congestion and Insulin dependent sugars not going down under 250 stays there to 300. The clinical course of the events as follows: on oxygen had major congestion for 3 weeks has subsided. Insulin dependent sugars level was between 110 and 130. Since the vaccine it would not go down under 250 stayed there to 300 with same insulin requirements. The patient visited the physician office for the events. On 18May2021, COVID test post vaccination: Nasal Swab was Negative. The events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The outcome of the event on oxygen had major congestion was resolving and the outcome of other event was not resolved at the time of this report.  Information about lot/batch number has been requested.
Noticed rash in area of injection one week after vaccination.  Rash was about 3 inches by 4 inches.  It stayed solid for about 36 hours and then went away leaving a circle of the rash at the outer most area .  Slight rash is still visible 2 days following first noticing it.
Received MMR, Varicella and Comvax vaccinations at 1 year checkup (given 04/28/03).  Nine days later (5/7/03)he presented with an apparent viral illness (fever, irritability, decreased appetite). On 5/21/03 (23 days post vaccination) he presented with a petechial rash and fussiness.  Platelet count was 7000.  (A prior value of 363000 was obtained 3/24/03).  Subsequent laboratory platelet results have varied from 22000 to 120000.  No other lab values have been out of normal range.
Patient raised hand and noted to be pale. Was asked if okay and noted that eyes rolled back and became diaphoretic . Paramedics called. Patients legs lifted and ammonia applied. Patients color started improving and patient started speaking. Patient stated " I want to lay down". Patient was taken by paramedics on stretcher
Some of the vaccine leaked down her right arm; A spontaneous report was received from a consumer concerning a 66-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine leaked down her right arm.  The patient's medical history was not provided. Concomitant product use was not provided.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 309K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection and the vaccine leaked down her right arm.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event vaccine leaked down her right arm was considered resolved.; Reporter's Comments: This case report concerns a non-serious unexpected event of a 66-year-old female patient who experienced vaccine leaked down her right arm (Incomplete dose administered) for mRNA-1273, lot # 309K20A. There were no reported AEs associated with this case of incomplete dose administered
4 hours after vaccine administration, opposite arm became red and swollen. Later, injection side became swollen and red. Seen in ER, prescribed Benadryl and Solumedrol.
patient was administered an expired dose of ACTHIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional.  This case involved 1 year old female patient was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  On 27-Jul-2021, the patient received fourth 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ355AA and expiry date: 24-Jul-2021) (Frequency = once) (Strength = standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that,"Caller wanted to know if that dose could be considered valid if blood work were drawn and analyzed on the patient."  This case was an actual medication error case due to expired vaccine used (latency: same day)   At the time of reporting, no adverse event  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 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.
Case number PHEH2016US023337, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 41 years old  male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in left arm on 14 Jan 2016. On 14 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this medication error.
swollen and redness in the under eye area for both eyes. I had dermal fillers (hyaluronic acid) in that particular area around two months prior to the vaccine.  The symptoms are improving without any treatment.
Day of vaccine- (R) arm swollen- Next day- Oblong, swollen area size of an egg Soreness-warm to touch no fever
Case number PHEH2014US007648 is an initial spontaneous report received from a nurse on 15 Apr 2014 with a follow-up received on 09 May 2014. This report refers to a 22 year old female patient. Her medical history was not reported. Concomitant medication included GILDESS FE 1/20 for birth control. Past vaccination included meningococcal vaccine (unknown manufacturer) on 18 May 2006. On 15 Apr 2014, at 10:29 am, she was vaccinated only with the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X13067) into left deltoid via intramuscular route and did not receive the Men A lyophilized conjugate. It was reported that the two vials were not reconstituted for administration of vaccine. She returned for correct administration of MENVEO vaccine on 22 Apr 2014. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow-up received from a nurse on 09 May 2014: Patient's demographics, concomitant medication, past vaccination, site and time of vaccination were updated.
He got very pale sick to his stomach and started dry heaving. Fainted for a few seconds and then came to. Slept for 1.5 hours then woke up  with a very bad headache and vomited. Went back to sleep for 3 hours and work up feeling normal again. Ate, had color, active... all seemed well.
A day after receiving the vaccine, my left arm was sore and I started developing mild flu-like symptoms including mild cough and light body aches. The next morning, I felt very sick, runny nose, terrible cough, massive headache, and body aches. I went and took a COVID-19 test to see if I had contract the virus. I had a virtual appointment with my doctor the next day and she suggested the Paxlovid infusion. I went to receive the infusion the following day, 04/29/2022 and began recovering a day or so after. As of today, I only had mild cough and headache, nothing that can't be managed.
Within a few hours of shots pt developed low grade fever.  Subsequently the next day got  profuse watery diarrhea (only 1 episode of blood in stool).
6 days post vaccination experienced fatigue that has continued to present date; hot flashes, especially to head; clammy skin; insomnia.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE OF THALAMUS, UNSPECIFIED TYPE AND ARTERY
pt exp legs weak, tired, malaise, h/a, loose stools for 1 day following vax;
On 10/18/07 around noon she started feeling bad - headache, runny nose, fever. Went to bed around 11:00 PM. Woke me (mother) up yelling. She was hallucinating, very frightened and agitated. Thought her room was "torn up" and "seeing pieces of stuff floating everywhere." Felt very hot (fever). This went on for about 4 hours.
This spontaneous report was received from a 64 year old male patient (who was a company representative). On 25-JUL-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent. On 26-JUL-2017, the patient experienced influenza like illness and nausea. The outcome of influenza like illness and nausea was reported as not recovered/not resolved.
At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case from, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905321, 201905322, 201905324 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Raised, hive like rash with significant itching over whole body below nipple line on Friday. Started Benadryl 25mg at 6pm. recurs exactly 12 hours after Benadryl. Today is Sunday 10/20/13 and it continues.
Patient reported increased shortness of breath and headache since 1st COVID vaccine. Stated "I felt like I was drowning last night and I took a Lasix." Symptoms improved with Lasix. Also reported increased cough and sputum production. She refused admission but   did receive dexamethasone 10 mg IV, ketorolac 20mg IV and Norflurane spray in ED.
This case was reported by a nurse via sales rep and described the occurrence of therapy non-responder in a 58-year-old female patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number 995J5, expiry date 6th February 2017) and ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). On 20th January 2015, the patient received the 1st dose of ENGERIX B adult. On 20th February 2015, the patient received the 2nd dose of ENGERIX B adult. On 17th July 2015, the patient received the 3rd dose of ENGERIX B adult. On 15th September 2015, 238 days after receiving ENGERIX B adult, 207 days after receiving ENGERIX B adult and 60 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possibly related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was one of the seven reports reported by an occupational nurse for patients tested negative for hepatitis B titers following vaccination with ENGERIX B (see cases US2015135763, US2015GSK136757, US2015GSK136759, US2015GSK136760, US2015GSK136761 and US2015GSK136762). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titers. The patient concerned in this case received 1st dose of ENGERIX B adult vaccine on 20th January 2015. On 20th February 2015, the patient received the 2nd dose. On 17th July 2015, the patient received the 3rd dose. On 15th September 2015, 238 days after receiving 1st dose of ENGERIX B adult, 207 days after receiving 2nd dose of ENGERIX B adult and 60 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for hepatitis B antibodies and it was found to be negative with value of 2.4, causing the patient to be a non-responder to the therapy.