chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, 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 (2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received an expired booster dose. The vial was punctured more than 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported Expiration time 12:08am on 07-Dec-2021. Administered time 8.30am and 8.31am on 07-Dec-2021.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-405922 (Patient Link).
This spontaneous case reported by a consumer, describes the occurrence of myalgia (arm soreness) and headache in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 vaccination. Concomitant products included Dicycton and multivitamins & minerals plus Lutein for an unknown indication. On Feb 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 12, 2021, patient experienced myalgia (arm soreness) and headache. The patient was treated with Tylenol (paracetamol) ongoing since an unknown date for blood pressure, at an unspecified dose and frequency. At the time of the report, myalgia (arm soreness) and headache outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscularly unknown.
Patient received flu shot on 11/8/20 and was feeling fine the days after but then started experiencing pain in his shoulder. When he would turn his head to the right he would feel a tingling from his neck down to the injection site. Some days he experiences tingling in his right arm and fingertips. It has only gotten worse since the vaccination. I (pharmacist) instructed patient to see a doctor for his symptoms and will report to VAERS.
she experienced local reactogenicity; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of reactogenicity event in a adult female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (unknown arm). On an unknown date, an unknown time after receiving Boostrix, the patient experienced reactogenicity event (Verbatim: she experienced local reactogenicity). The outcome of the reactogenicity event was not reported.   The reporter considered the reactogenicity event to be related to Boostrix.     The company considered the reactogenicity event to be related to Boostrix.   Additional Information: GSK Receipt Date: 23-SEP-2023 The age of the patient was reported as 5 decades. The reporter reported that the patient mentioned receiving Boostrix and experienced local reactogenicity. The reporter consented to follow up.
Every since I had the 2nd vaccine I have had daily headaches, I am so tired and weak. My arms and legs hurt every day, really bad. I have no strength. I have to muster up the strength to just walk around. I just feel terrible. This is not normal for me. I never experienced any of these symptoms before this shot. I was a healthy person pre vaccine.
On 12/23/99, pt had seizure, went to ER. Had fever & flu symptoms.
sore arm; A spontaneous report was received from a consumer concerning a 82-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm.  Treatment details included Advil.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm was unknown.
@ 6:50 pm- Resident lying in bed with signs of apnea also has o2 in progress per Nasal cannula. Call bell in reach. v/s 53/20, 12, 101.5, o2 is 92%. Family choice not to send out to hospital bc resident had HX of periods of apnea  @ 9:30 pm-  resident had no means of life, vitals wasnt reading at this time.
dime size lump several days later. not painful, not red,  can be felt under the skin
Information has been received from a physician concerning a 15 year old female who was vaccinated intramuscularly with her first dose of Gardasil.  Subsequently the patient fainted after receiving the dose.  The physician mentioned that the patient faints after every shot and blood draws.  It was not mentioned whether or not the patient had received anymore doses of Gardasil.  Subsequently, the patient recovered from fainting.  Additional information has been requested.
was maladministrated with Kinrix  on March 22 2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by manager supervisor. The 15 month old patient received Kinrix, which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up. This case has been linked with US2021072205, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072205:same reporter
Injection site still feels like a bruise since I got it. This is the only side effect. I did not get any other side affects. It is not painful but if I put pressure on the injection site, it feels like a bruise.
Myalgia Moderate soreness at injection site 1st and 2nd day of vaccination  Narrative:  Patient had 1st covid vacc 12/30/2020. Patient reported moderate soreness at injection site 1st and 2nd day. Patient also reported body aches day of vaccination.
Information has been received from a registered nurse concerning a patient who received complete series of VAQTA and had tested positive for Hepatitis A. It was unknown if the patient sought medical attention. At the time of report the patient's status was not recovered. Additional information has been requested.
After administration, when documenting PPSV23 I noticed that it was past its expiration date of 6/28/21.
Patient reported inability to lift arm for about 3 days after the vaccine. She reported using physical therapy herself to help with range of motion. She reports her arm is getting better than when it first occurred. Patient also reported a rash that developed 10-28-18 on the tops of her feet and legs. She reports one side is worse than the other.
I had my routine regular heck up, and the lab work showed I was anemic. I am seeing a hematologist who has yet to figure out what has caused this. He has put me on a iron supplement. He will  perform a bone marrow biopsy depending on my next labs. His name Dr. (Privacy). I  have been seeing many doctors since and still have no answer how this occurred. I feel I will have to live with this forever.
After one hour, patient returned to clinic with swelling, redness, and itching at injection site.  We verified that she had received FluBlok because of reported egg allergy history.  Patient took Benadryl to help with symptoms.
I thought I was having a heart attack. My heart was racing and I had pain in my chest.
Patient calls with body rash, fever, and "squishy" lump on left wrist. No office visit patient declined.
No adverse reactions. PEDIARIX given on 3-29-10 had expired on 3/26/10 Lot # AC2161B149AA. Reported to provider.
hospitalized for 3 days and was sick for about a month because of vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (hospitalized for 3 days and was sick for about a month because of vertigo) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (hospitalized for 3 days and was sick for about a month because of vertigo) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to VERTIGO. At the time of the report, VERTIGO (hospitalized for 3 days and was sick for about a month because of vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information provided.  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.; Sender'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.
I HAD VACCINE IN UPPER RIGHT ARM ON 12/09/2009 I HAD FEVER, MUSCLE ACHES, COUGH DURING NIGHT OF 12/09/2009 ON MORNING OF 12/10/09 HAD SEVERE PAIN IN RIGHT HIP  UNABLE TO LAY DOWN OR SIT  SEVERE PAIN CAUSED ME TO LIMIT WHEN WALKING AND HAD GREAT DIFFICULTY TRYING TO SIT OR GET UP PAIN WAS SEVERE ON 12/10/2009, 12/11/09, 12/12/09, AND ON 12/13/ 09.  PAIN STARTED TO LET UP ON AFTERNOON OF 12/13/09 AND IS MILD TODAY, 12/14/2009. WILL BE HAVING CONVERSATION WITH HEALTH DEPARTMENT AND PRIVATE PHYSICIAN TODAY.  STILL HAVE COUGH.
Airman medic went to administer vaccine into patient's deltoid and after inserting the needle but before she could depress the plunger, she lost grip of the syringe and it fell to the floor. patient was poked a second time and given the vaccine.
This spontaneous report as received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition, historical medication and concomitant medication. On 27-OCT-2016 the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU lot number was unknown, expiration date - 06-OCT-2016. No adverse was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. The ZOSTAVAX did not had any temperature excursions prior to administration. Additional information is not expected as reporter did not wants to get contacted.
small vessel thrombotic event; lacunar infarct: ventral posterolateral thalamus
Within a couple of minutes, post vax, the pt broke out with generalized red, flat blotches all over his body and was fussy. Benadryl was given.
Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 30-year-old female patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. Healthcare professional wanted to remain anonymous as she was doing a clinical rotation there.
runny nose; lymph node pain in her breast; headache; feeling tired; chills; temparature of 97.3; some armpit lymph node area dicomfort/; injection site pain; body ache; little bit of dry cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), COUGH (little bit of dry cough), RHINORRHOEA (runny nose), LYMPHADENOPATHY (some armpit lymph node area dicomfort/) and INJECTION SITE PAIN (injection site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (body ache), COUGH (little bit of dry cough), LYMPHADENOPATHY (some armpit lymph node area dicomfort/), INJECTION SITE PAIN (injection site pain), FATIGUE (feeling tired), CHILLS (chills) and PYREXIA (temparature of 97.3). On 20-Mar-2021, the patient experienced RHINORRHOEA (runny nose), LYMPH NODE PAIN (lymph node pain in her breast) and HEADACHE (headache). At the time of the report, PAIN (body ache), COUGH (little bit of dry cough), RHINORRHOEA (runny nose), LYMPHADENOPATHY (some armpit lymph node area dicomfort/), INJECTION SITE PAIN (injection site pain), LYMPH NODE PAIN (lymph node pain in her breast), FATIGUE (feeling tired), CHILLS (chills) and PYREXIA (temparature of 97.3) outcome was unknown and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: ADR Form attached- Reporter new address updated, patient height and weight given . Attached excel document with ADR form
Vaginal ulcers in non sexually active patient. Slight irritation and itchyness occured in the vagina two days after the vaccine was administered. Over the course of two days, three painful ulcers formed around the vagina. Ulcers lasted five days and healed after Zovirax cream was perscribed and used.
MUSCLE ACHE; HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced muscle ache. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, headache and tiredness was not reported. This report was non-serious.
pt recv vax; 12x6 cm reddened area on lt upper arm, edematous, tender to touch; dx in er as typhoid rx; tx w/ dph, motrin & ice packs used;
Adverse event/severe side effects; Lack of effect/0 Zero antibodies; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (Adverse event/severe side effects) and DRUG INEFFECTIVE (Lack of effect/0 Zero antibodies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event/severe side effects) and DRUG INEFFECTIVE (Lack of effect/0 Zero antibodies). At the time of the report, ADVERSE EVENT (Adverse event/severe side effects) and DRUG INEFFECTIVE (Lack of effect/0 Zero antibodies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up information included no new information On 26-Aug-2021: Translation received on 31-AUG-2021 contain significant information that include Event added. On 26-Aug-2021: Translation received on 31-AUG-2021 contain significant information that include Event added. On 26-Aug-2021: Upon internal review on 02-AUG-2023, significant correction was performed to delete the event of immunodeficiency and merge it in the verbatim of the event of Lack of drug effect and also to update the report type in the case
Vaccine in both arms. Red rash on chest and face, hives on both arms at injection sites. Lips blistered, feeling as if they were sunburned. Itching but no pain. Very annoying.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Information has been received from a physician, via a company representative, concerning a female patient who on an unspecified date, was vaccinated with a dose of Gardasil (Lot # not provided). Following the vaccination, the patient fainted, and then recovered (duration not specified). No further details were provided. The patient sought unspecified medical attention. The physician reported that two other female patients also fainted after vaccination with Gardasil (Lot # not provided) (WAES #0707USA04932, 0708usa00118). Additional information has been requested.
MMR #2-to lab,   BP 100/80 urgent up 90/80 cat 98%
Neuropathic pain syncope, redness at sight, light head near syncope high fever redness over body.
This spontaneous report was received from a company representative while attending a digital marketing training from internet website containing information about a female patient between 55 to 64 years old. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-FEB-2008, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) for prophylaxis. Subsequently, on 14-FEB-2018, the patient experienced shingles and joint pain and was given an unspecified treatment. At the time of reporting, the patient's outcome was unknown. The patient sought medical attention through an office visit. No further information was provided.
Pt. reports she ran fever the evening & night after receiving her flu vaccine. Also felt achy with chills that evening. No medication taken. Symptoms subsided the next day.
Nausea and vomiting 5 minutes after administration, patient was hot and sweaty- symptoms resolved after vomiting; observed for 30 more minutes and then patient was well enough to leave
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ) by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 11-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Pain at injection site at +1 hours, subsided after 3 days Fever onset at +9 hours, peaked at 101.0 F, subsided after 36 hours then returned 12 hours later, subsided next morning. Fatigue onset at +9 hours, subsided after 72 hours
Very weak and tired, hot and cold, back of throat and ears soar,  under arms and neck sore,  nipples and bottom of feet burning/stinging. Body aches and nausea. Tylenol, peppermint tea, soak in bath with Epsom salt.
No other AE; The caller said a 3 year old patient received PROQUAD and VARIVAX today; This spontaneous report was received from registered nurse and refers to a 3-year-old. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 01-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #W003821, expiration date: 02-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, lot #W010524 rHA, expiration date: 25-SEP-2023,  (strength, and route of administration were not provided) administered for prophylaxis (overdose.)  No adverse symptoms were reported.
Had cold sweats and aching all over x 4 days. Still (R) upper chest pain, worse with cough and moving (R) arm. Pain and stiffness mainly knees and shoulders. No fever, no more SOA. Knees have been swollen.Did not have arthralgias before vaccine.