chrisvoncsefalvay/vaers-outcomes huggingface dataset:
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
This is one case out of a cumulative total of 222 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 14 January 2014. These 222 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 14 January 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3253AA received on 10 February 2010, lot number C3554AA on 14 April 2010, lot number C3232AA on 09 June 2010 and lot number C3754AA received on 25 July 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 01 November 2013, approximately 2 years after the last dose. On 03 November 2013, the subject developed a cough and paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 18 November 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
The arm was squeezed when the vaccine was administered; Soreness; A spontaneous report was received from a Consumer concerning a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as sore arm , and that the arm of the injection was squeezed.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 1st Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch: 012L20A) in the Arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch: 012L20A) in the Arm for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient had sore arm, and concerned whether the vaccination technique by squeezing the area during injection is OK.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   On an unknown date, the outcome of the events as sore arm, and that the arm of the injection was squeezed were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 11AM on 30SEP96;mom phoned next day & reported that church had severe nosebleed around 4:30-5PM on 30SEP96;
Fever, chills, body aches - 2 tabs Tylenol extra strength at 2:30am 4/17/2021 - symptoms abated after 30 minutes
This case was reported by a other health professional via sales rep and described the occurrence of injection site induration in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site induration and injection site erythema. On an unknown date, the outcome of the injection site induration and injection site erythema were unknown. It was unknown if the reporter considered the injection site induration and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. At the time of the call, patient specifics and lot number were not available. The female patient experienced a quarter-sized induration and erythema. GlaxoSmithKline representative was given info from the medical assistant, who would give a call early next week to provide specific information about patients and vaccine lot. She told the representative that she felt that the female and the male with the more mild adverse events aligned with what was in the patient information. This was one of 3 cases reported by same reporter.
Painful swelling in armpit; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 03Jun2021 at 16:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to peanut, treenut, shellfish and milk. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jun2021, the patient experienced painful swelling in armpit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event painful swelling in armpit was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
legs were weak and can't barely walk; legs were weak and can't barely walk; bad Cough; sore throat; headache; nausea; chills; This is a spontaneous report from a contactable consumer (patient). This 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route on 18Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Jan2021, the patient experienced nausea, chills, and headache. On 22Jan2021 she experienced bad cough, sore throat, legs were weak and can't barely walk. The outcome of the events nausea, chills, headache, bad cough, sore throat, legs were weak, and can't barely walk were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Patient was given an immunization with AFLURIA at pharmacy by pharmacist 9/11/15. On Tues Oct 13, 2015, pt called pharmacy and spoke to reporter. Patient said she had been having deep muscle pain at the injection site since getting the injection. Not everyday or event when exercising but when she lies down in bed or resting when pressure on that arm. I called her physician to tell them. As of last week there was still deep muscle soreness. She said this didn't happen previous year but did happen 3 yrs ago from another pharmacy vaccination.
breakout of shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation, age at vaccination unknown. Medical history included chickenpox from an unknown date. The patient's concomitant medications were not reported.  The patient experienced breakout of shingles on an unspecified date after having the Pfizer COVID-19 vaccine. She said her doctor has advised her to report her reaction to the vaccine to Pfizer. It might be a long-term effect of the vaccine. The patient commented that it is very unusual that the vaccine does not trigger the chickenpox virus. That could be a high possibility said the doctor. Patient did nothing unusual, no other medical intervention (treatment) aside from the vaccine. Patient had chickenpox as a kid and patient stated it is said the virus stays dormant. Patient have no other health concerns. This vaccination has only been the only thing different. Patient had a breakout 2 months later. Outcome of the event was unknown. The event was reported as non-serious.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Is inflamed; Large welt; Red; Angry looking left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Is inflamed), URTICARIA (Large welt), ERYTHEMA (Red) and RASH (Angry looking left arm) in an 80-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INFLAMMATION (Is inflamed), URTICARIA (Large welt), ERYTHEMA (Red) and RASH (Angry looking left arm). At the time of the report, INFLAMMATION (Is inflamed), URTICARIA (Large welt), ERYTHEMA (Red) and RASH (Angry looking left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment was taken for symptoms..
pt recv vax & devel an inj site tenderness for approx 2 days;
On 1st day after shot (Fri), felt achy, tired and feverish. I was recovering from that when I broke out in a very itchy rash with several blisters on torso Saturday night. Thinking that it might be an allergic reaction, I took Zyrtec and went to bed. It was about the same on Sunday but by today (Monday) it is clearing up.
administered only the liquid component of Menveo yesterday; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa938a) for prophylaxis.   On 07-AUG-2023, the patient received Menveo. On 07-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid component of Menveo yesterday) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 The pharmacist stated that another staff member administered only the liquid component of Menveo yesterday (the day before reporting), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Lightheadedness onset at 3 minutes (approximately) after the vaccine. Felt like I would be unsteady on my feet if I stood up. So kind of a dizziness/vertigo.
Patient sitting upright on exam room bed 4:10p. 4:11p after pt received HPV vaccine at 4:10p pt went backward on bed, lips and face pale, pt alert, eyes following nurse and open, P=60, B/P=88/60 at 4:12p. Doctor instructed pt to lay down on bed. 4:19p = pt color returning. 4:35p B/P 92/68, P-68, pt talking to family members states he feels fine. 4:44p = B/P 98/62, P-72, pt discharged. Responsive, no LOC.
Immediately afterwards she was wired up and refused a nap. Very thirsty and energized. She also became very irritable and cried a lot. Very soon after (before noon) she broke out in hives on her legs, stomach back, in the crease of her arms. I gave her a cool bath and gave her benadryl as well as used benadryl cream on her outter skin as well as rubbed Curel all over her body this calmed her a bit. This morning I called the doctor because I was unsure if she was allergic. This evening towards bed time. She broke out worse in hives on her cheeks, legs, arms, lower back. I immediately gave her a bath and administered cream on her body again. I am very worried. None of my kids have ever reacted to vaccines like this. I also called the ER line but there was no answer so I left a voicemail for someone to call me back. She has been fussy all day but has been itching and scratching parts of her body. I called her doctor's office three times but will be taking her to visit him tomorrow.  Did call
Patient admitted to hospital on 11/19/2021 with Covid pneumonia.  He received oxygen, dexamethasone, and remdesivir.  He was discharged from the hospital on 11/22/2021.  He received 4 doses of remdesivir in the hospital and completed a full 10 day course of dexamethasone as an outpatient.
rash underneath her armpit; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a rash underneath her armpit on 25Apr2021. so she wanted to know if the rash may still be related to the vaccine even if it started to appear days before she got her 2nd dose. She said that aside from that, she felt okay and had no temperature. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT STATES PNEUMOVAX 23 VACCINE CAUSED His INJECTION SITE TO SWELL UP. PAIN WAS HARD TO BARE. THE SWELLING TRAVELED TO HIS PALMS THE FOLLOWING DAY. SWELLING HAS ALSO REACHED HIS BODY.
Patient reported Shortness of breath and that she almost passed out after walking up the stairs. She reported fluctuation of heart rate for about an hour, heart rate went up to 119 then drastically dropped to 36 then up to 147 then back to 119.
Patient reported on 1/9/2021 that her Fluzone HD Quad which she received on 12/1/2020 caused bad reactions.  Her throat felt burning after 1 hour later.  She felt her chest tightness without any breathing problems. Shortly afterwards, she developed sore and dry throat.  This symptoms lasted couple of days.
A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Dec-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (A booster dose provided to a patient from a vial that was opened in the fridge, the first puncture to the vial was at 9:22am 12/6.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were provided.No treatment medications were reported. Reporter did not allow further contact.
Redness and swelling of right upper thigh with lg. firm lump temp 102-102 deg x 24 hrs
Shortly after getting home, the patient started to experience swelling in the left arm, then approx 2-3PM the same day it became red, and felt like it was burning. She started to take EXCEDRIN EXTRA STRENGTH at home right away. It was from the elbow to the shoulder. She called the pharmacy and spoke with somebody on the following day 1/26/19 at 12:58PM. The patient was advised to use cold compresses, BENADRYL, and a pain reliever and if situation got worse to seek medical attention. The patient used cold compresses and continued using the EXCEDRIN every four hours until about 10:30PM on 1/26/19. The patient has stated that it is much improved today 1/27/19. She hasn't used any therapies since last night 1/26/19.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (red large rash to arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03721B) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced RASH (red large rash to arm). On 27-Apr-2021, RASH (red large rash to arm) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment details were provided.
4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe.  Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge  Patient currently on estrogen placement therapy-discontinued     Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates  Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough
Left lower arm now has a warm, red bump where injection was administered, per mom. Patient was given Ibuprofen by mom for pain and swelling.
Mild difficulty breathing.  It felt like a mild asthma attack. Able to breathe with a little extra effort.
Patient woke with a 101 degree Fahrenheit fever and swollen lymph nodes. Patient fainted in the bathroom, was able to get back up and then fainted again on her way to the living room. She has taken ibuprofen and Tylenol and had diarrhea and excessive sweating. Three days later her "head is still spinning".
Got sick afterwards; This is a spontaneous report from a Pfizer sponsored program. A non contactable female consumer (patient) reported that this patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date single dose for COVID-19 immunization. Medical history and concomitant drugs were not provided. The patient got sick afterwards. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Information has been received from a 69 years old female patient referring to herself. The patient had no medical history and no known drug allergy. On 02-DEC-2015 the patient was administered with a dose of ZOSTAVAX (lot#, dose, frequency were unknown; route reported as injection) for shingles. There was no concomitant therapy. On 02-JUL-2016 (also reported as 6 months after being administered of the vaccine), the patient developed "a bad case" of the shingles. The patient had sought medical attention via speaking with physician. Valacyclovir hydrochloride was given as treatment for adverse event. No lab diagnostics was performed. The patient was not recovered from shingles at the time of the report. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
Palm sized red rash circle on left leg and palm sized red rash on back of left leg.  Adv mom to apply cold packs to upper thighs and give Tylenol every four hours mom will call tomorrow with follow-up.
4 hours after the vaccination, my arm began to feel very sore and I was getting fatigued, took 2 Advil.  Slept poorly that night, was very chilled.  In the morning, had a headache, muscle aches, and chills, throughout the day.  Took 2 Advil 4 times throughout the day.  Was still feeling poorly at 11pm, teeth were chattering.  The next day had no chills or muscle aches, but still had a headache and weakness, along with some overheating (I don't know how else to explain it, would just get hot, but it wasn't a hot flash--though I haven't had those yet).  The following day most of the symptoms are gone, my arm is much less sore, though I still feel slightly weary.
Child became pale and limp at 14:59. Had cyanosis of lips with wheezing at 15:00. Epinephrine .3cc, SC, LL and Benadryl 12.5mg, IM, RL given at 15:00. 911 called with laying down child on floor and checking respirations. At 15:00, R-24; P-110 and BP 70/30. Lethargic response to verbal stimuli, expiratory wheezing heard bilaterally per stethoscope; paramedic here and assisted to lay seat. Pulse Ox-98% on room air. Sent to hospital via ambulance. Was transferred to another hospital for 23 hours of observation to her pulmonary management. Discharged on 5/2/01 from hospital.
Client requested Moderna booster dose but received Janssen 0.25 ml dose in error.
No adverse event. Vaccine administration error: Comirnaty administered to a 7  year old.  (the patient's weight is above the WHO growth chart's 50th percentile for 12 year olds.)