chrisvoncsefalvay/vaers-outcomes huggingface dataset:
0.5mL administered for booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (0.5mL administered for booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5mL administered for booster dose). On 30-Nov-2021, ACCIDENTAL OVERDOSE (0.5mL administered for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 10/2022. I had a sore throat, I was fatigued, a mild fever and a productive cough. I only took over-the-counter medications for my symptoms. In 03/2023, I had bronchitis, and I went to an urgent care center and got a prescription for an antibiotic. I had a cough for a very long time after having bronchitis.
Client's son reports that client complained of throat tightness, new onset coughing.  Client was treated on site by Fore Rescue and transported to Hospital by ambulance.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MAC" (unspecified if ongoing); "Known allergies: Noacin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 13Dec2022 to 18Dec2022, patient received Paxlovid for COVID-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning a 4 month old male who on 08-OCT-2008 at about 12:00 was vaccinated with a dose of PNEUMOVAX (LOT# 658074/0803U) accidentally rather than PREVNAR. The patient received his first dose of PREVNAR in August 2008 (2 months ago) and was to receive dose 2 when the error occurred. The registered nurse indicated that it would be helpful if the "labeling could be bigger" to prevent future errors. Within 72 hours post vaccination, the patient experienced a cold. However, the nurse did not think that there was a link to the vaccination. The patient's outcome was unknown. It was not specific if the patient sought medical attention. Additional information has been requested.
Red, swelling, pain left arm moving up to his neck. Limited ROM. Tenderness.
administration of vaccines off schedule in order to catch the patient up on vaccineswith no reported adverse event; Initial information was received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age/gender patient who involved in administration of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] off schedule in order to catch the patient up on vaccines with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (dose, strength, lot number, route, administration site, expiration date: Unknown) for Immunization (immunisation) off schedule in order to catch the patient up on vaccines with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (administration of vaccines off schedule in order to catch the patient up on vaccines with no reported adverse event).  Outcome: Unknown for the event administration of vaccines off schedule in order to catch the patient up on vaccines with no reported 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.
She started with hives and itch all over her body on Saturday around 2 pm. she put some hydrocortisone OTC to alleviate the itch but didn't help her out. On Monday morning, her arm become purple and very swollen. Her scalp was very itchy,. she was very tired and weak. She went to pharmacy around noon and pick up Benadryl. She took the first dose which didn't help her, so she took the second dose which makes her super drowsy. She called us at  pharmacy, and I recommend calling her PCP. her PCP advise her to take the Benadryl for couple of more days. Her redness and swollen arms got better over the week. I spoke with her, and she's better.
Information has been received from a physician concerning a female who on 17-Jun-2008 was vaccinated intramuscularly with the second dose of GARDASIL (lot# 659180/1758U). Her first dose was on 31-Mar-2008. The patient has no concomitant conditions and medical history. She has no drug reactions or allergies either. Subsequently the patient experienced shortness of breath, dyspnea, malaise and fatigue. The patient has been several times at an urgent care center. She was last seen by physician on 04-Sep-2008 and the physician wrote in her notes "symptoms resolving, possible GARDASIL reaction". At this appointment the patient stated that she is experiencing transient dizziness that last for 1 minute. At the time of the report the patient had not recovered. No additional information is available. Additional information has been requested.
This case was reported in a literature article and described the occurrence of uveitis in a female subject who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, an unknown time after receiving Human papilloma type 16 + 18 vaccine + AS04D, the subject developed uveitis. Serious criteria included GSK medically significant. The outcome of uveitis was unknown. The investigator considered that there was a reasonable possibility that the uveitis may have been caused by Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided: This case was reported in a literature article and described the occurrence of vaccine-associated uveitis in a female aged between 11 and 29 who was vaccinated with unspecified human papilloma virus (HPV) vaccine (manufacturer unknown). The patient was part of observational study conducted to collect data on cases of vaccine-associated uveitis reported from 1984 to 2014 to three spontaneous reporting databases on adverse drug events. In addition, a literature search was performed using the keywords of uveitis, iritis, iridocyclitis, or vitritis, in combination with vaccines, hepatitis A, hepatitis B, human papilloma virus vaccine (HPV), Bacillus Calmette-Guerin (BCG), Brucella, diphtheria, pertussis and tetanus (DPT), herpes, influenza, measles, measles, mumps, and rubella (MMR), pneumococcal, smallpox, tetanus, typhoid, Heine Medin, varicella, yellow fever, and zoster vaccine. No information on patient's medical history or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified HPV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). (Information on which dose of a particular vaccine was associated with uveitis was not available in the reporting systems.) On an unspecified date between 1984 and 2014, between 2 and 511 days after vaccination with unspecified HPV vaccine, the patient developed uveitis. Treatment was unknown. The outcome for the event was unresolved. The authors considered the event of uveitis associated to unspecified HPV vaccine. The authors concluded "While uveitis may be a rare adverse effect of vaccines, awareness of this potential reaction to vaccines is important, as is reporting such occurrences to adverse drug reaction registries. That hepatitis B vaccine accounted for a disproportionate number of cases certainly piques curiosity about contributing factors for uveitis in association with hepatitis B vaccine. In a similar vein, we are also left with the question of why a disproportionate number of cases of vaccine-associated uveitis occur in females (199 in females versus 77 in males in our data). Future studies of vaccine-associated uveitis could focus on active surveillance and rigorous clinical evaluation of patients presenting with uveitis temporally related to vaccination". This is 1 of 14 valid cases reported in the same literature article. This article is not available for regulatory submission due to copyright restriction.
Large lumps in both arms.  1.) Patient first noticed a large lump in the left arm (non-injection arm) two days after the vaccination.  The lump still remains.  2.) Ten days later, a red and itchy lump/rash appeared in the right arm (injection site arm.) There are two "lumps" on the left arm.  3.) Two days after that, a third lump appeared in the left arm (non-injection site.) Patient has consulted a primary care physician and two allergists.
Extreme fatigue, weakness, leg muscle pains/pins and needles, lightheadedness, shortness of breath, tingling lips, hand tremors
Severe headaches, bodyaches, nausea vomiting and weakness persisting beyond the typical 2-3 days post vaccination. Today 3/9/2023, she is reporting progressive weakness in lower extremity, headache has improved and very fatigued in the second half of the day. She went to the ED on 02/27/2023 had investigations and imaging studies that were not conclusive. I have recommended that she goes to the ED ASAP again today to rule out Guillian Barre syndrome given the progressive weakness
SEVERE RIGORS; SEVERE ARM PAIN; FELT UNWELL; HEADACHE; This spontaneous report received from a consumer concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced severe rigors. On MAY-2021, the patient experienced severe arm pain. On MAY-2021, the patient experienced felt unwell. On MAY-2021, the patient experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe rigors, severe arm pain, and headache on MAY-2021, and the outcome of felt unwell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210817407 and 20210817490.
This spontaneous report was received from a physician via a company representative concerning an 18 year old male patient with no drug reactions or allergies. The current condition of the patient included needle phobia in which he experiences nausea or passes out or has a reaction every time he sees a needle. On 01-MAY-2013, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date reported as H014645 and 27-MAR-2015 respectively, dose unspecified), intramuscularly in the left arm. Concomitant therapy included MENACTRA (lot number, expiry date, dose and route unspecified) injected at the same office visit on 01-MAY-2013 with GARDASIL. On 01-MAY-2013, the patient passed out for five seconds after receiving his first dose of GARDASIL. The patient was still in the physician office when he passed out, and he revived a few seconds later. The patient was given a piece of unspecified candy and unspecified juice to drink. He was retained in the physician office for an unspecified amount of time for monitoring after he passed out. No lab tests were performed. The patient appeared to be fully recovered after reviving and left the office on 01-MAY-2013. The relatedness for the event was unknown for GARDASIL. Upon internal review the event, passed out was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
Patient received second RZV dose 1/7/19 at approx. 2pm. Patient called the next day to report the following: Patient with possible shingles injection reaction from yesterday. He had a really bad headache last pm getting slowly better today. Still rates h/a a 6. He is sweating and his arm is sore. His stomach is upset but no vomiting. He has no appetite and he doesn't feel like doing anything but lay on the couch. I will send this note for PCP for recs.
Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) in a 41-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 15-Jul-2021, the patient experienced BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included steroids and an eye cream.  Concomitant medications were not provided.  Patient thought she got first vaccine on 30-JUN-2021 or during the 1st week of July 2021. On 15-JUL-2021, she thought she was having a stroke, went to the emergency room and was diagnosed with Bell's Palsy on the left side of her face. Her left eye was not closing all the way and would not blink at same pace as the right eye. She told that it had gotten better but it was not back to 100 percent.  Company comment: 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.
The patient presents with Generalized weakness and hypoxia.  Patient states he has been feeling unwell for about a week.  Having fevers at home, cough, loss of taste, dyspnea, body aches.  Has been taking Tylenol.  Was vaccinated with Pfizer vaccine in February 2021.  For EMS initial saturations were 58% on room air, placed on a non-rebreather, given 350 cc fluids prior to arrival..  The onset was 1  weeks ago.  The course/duration of symptoms is worsening.  The character of symptoms is Generalized weakness.  Therapy today: emergency medical services and Oxygen.
Fever and hyperglycemia, hospitalized with DKA on 10/10/2021
Per phone call report from mother - 9-7-10 - Pt. became ill 1-2 days after vaccine with fever 103 degrees, sinusitis, tonsillitis, aches, fatigue. Saw nurse practitioner at clinic - DX. of above, Amoxicillin prescribed for 10 days. Pt. improved with antibiotics. Last dose of antibiotics taken 9-6-10 - symptoms of aches & sinus congestion returned 9-7-10. 9-7-10 1600 PC from mom. Reports pt. became ill with fever, sore throat, sinus congestion within 2 days of receiving MENACTRA on 8-24-10. States pt. had a fever of 103 degrees - aches, fatigue, sore throat headache & sinus congestion. Went to nurse practitioner- DX. of sinusitis & tonsillitis, prescribed Amoxic for 10 days, states strep. test negative. Pt. improved & then after last day of antibiotic 9-6-10 - symptoms returned. Advised follow-up with M.D. - ask re: mono test,? No insurance - advised list of low cost clinics mailed. (VAERS report started). 9-8-10 1330 PC to home, left message. 9-9-10 1230 PC to home, cell phone, left message. 9-10-10 PC with mom. States pt saw N.P. on 9-7-10 strep. test positive. Is on Azithromycin for 5 days - and is feeling better, back at school.
red splotches the size of a quarter to half-dollar in covid arm; itches near the injection site; Upper arm is hot; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730, Expiration date was not reported), via an unspecified route of administration in arm right on 23Mar2021 at 11:00 (at the age of 35-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included ongoing tuberous sclerosis and ongoing lymphangioleiomyomatosis and ongoing allergies to all barbiturates. The patient's concomitant medications received within 2 weeks of vaccination included everolimus (AFINITOR), sertraline, D3 (COLECALCIFEROL), Multi and loratadine, all were taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration in arm right on 02Mar2021 at 11:00 AM (at the age of 35-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 29Mar2021 at 10:00, the patient experienced red splotches the size of a quarter to half-dollar in covid arm, upper arm was hot and itches near the injection site. The reporter considered the seriousness of the events as non-serious. Treatment was not received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Pt states she has been having chest pressure and shortness of breath worse when laying flat since receiving Moderna booster on 11/19 form.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies were reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route unknown). No concomitant medications were reported. No adverse effects were reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Merck) VARIVAX. Follow-up information has been received on 03-AUG-2015. Telephone call was made to the medical assistant. A voicemail message was left requesting she return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information has been received on 05-AUG-2015, a call was received from the certified medical assistant who reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-month-old (reported as 1-year-old) patient of unknown gender. On 01-AUG-2015, the patient was vaccinated with improperly stored dose of (Merck) VARIVAX lot # L003775. The vaccine was. This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were updated.
pt recv vax; had fever of 103;apap given;11may96 devel red bumps & rash on lip and back;rash inc;to see MD if fever persists;pt ok, only few bumps & child scratches on head & neck;
pt recvd vax;became reddened w/ welp like rash immed p/ vax;T 98.6R;epi given;sxs resolving,resp clear;no distress;crying, pt threw up, HR 140;AP 136, T 96.2ax;susphrine per MD;
This spontaneous report as received from a registered nurse refers to a 17 years old male patient with no pertinent medical history, no drug reactions/allergies, no birth defects, no medical conditions and no illness at the time of vaccination. The patient was vaccinated IM with the left arm with dose 1, 0.5 ml GARDASIL (Lot number 0629AE) on 18-JUL-2012 at 11:00 A.M approximately. No other co-suspects were reported. There were no concomitant. The patient waited 15-20 minutes and was fine. He then went directly from the office to work as a lifeguard in 105F ambient temperature. The temperature outdoor was reported as 104. At approximately 2:40 - 2:45 the patient fainted while at work. The paramedics were called to the office. The patient revived quickly without required medical intervention and fully recovered on the same day. The was no treatment given for the event and no Lab Diagnostics were performed. It The patient sought medical attention called to the office. The relatedness for fainted was unknown for GARDASIL. It was also unknown if heat was related to the event. It has been determined that case # 1207USA009638 (serious case) is a duplicate of case # 1207USA008776 (non serious case) Therefore, case # 1207USA009638 (serious case) is being deleted from our files and the cases consolidated into case # 1207US008776 (non serious case). Additional information is not expected. This is one of several reports from the same source.
MOM STATES PATIENT HAD GENERALIZED BODYACHES, HEADACHE, NAUSEA AND VOMITING, FEVER UP TO 103F.