chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a doctor of pharmacy refers to an unspecified number of patients who on an unknown dates, might have received doses of PNEUMOVAX 23 (dose, route and lot numbers not reported) that had been exposed to temperatures not lower than -2.5 degrees C for unspecified periods of time, possibly since June 2012. No adverse effects were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, CHILLS, FATIGUE, MALAISE Narrative:
5-11year old Pfizer covid vaccine (10mcg/0.2mL) inadvertently administered to 12 year old patient on 8/18/22.  Patient received the correct dose for their initial covid vaccination on 7/27/22. Consulted Nurse Manager, ID team, and CDC online resources. Plan is to obtain a dose (30mcg/0.3mL) of the 12+ pfizer covid vaccine after 8 weeks from 8/18/22 . Patient and family are aware of adverse event and were involved in decision making process.
It was my heartbeat that was irregular and my pulse was higher than normal (between 92 and 105) and my blood sugar was running higher than normal (157 one day, then two normal days, 132, 149, then 132 again today). Blood pressure was lower 100/70 (blood pressure is normally 125 over 70).
Later that afternoon I felt like a ton of bricks hit me. Almost like I was going to faint. When I got home my arm was swollen and red. I started having a bad bowel movement, no fever, stiffness, joints aching, and dull aches. I had a hard time resting. The next day when I woke up, I had a bowel movement bad. When I went downstairs, I was bleeding from light to medium from my vagina. For 4 hours I had sharp pains in the middle of my chest. I went to see Doctor; my symptoms were gone for 5 days. Then 10 days ago my eyes were tearing a lot and painful. I went walking and had incredible pain in feet, ankle, knee, and I could barely stand. The next morning, I went to my PCP and referred me to a RA doctor and think it's an autoimmune disease.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Follow up information has been received from the Licensed Practical Nurse. The Licensed Practical Nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and dates of vaccine administration) available at this time. No further information was available at this time of report. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 15 years old Adolescent. The patient was vaccinated with GARDASIL on 26-SEP-2014. Lot was reported as J015378, expiration date 09-APR-2016 for the vaccine GARDASIL. Additional information has been requested.
Right leg had no feeling/wd not support weight.  Dizzy/Light Headed.  Blacked out. 8/26/09  PCP note received.  Pt in for PE on 6/29/09  HPV vax given./pc 9/21/09 Spoke with parent.  Still reports some numbness as well as new symptom of twitching of the fingers.  Has not seen a physician since the ER./pc
C/O OF DIZZINESS A MINUTE AFTER RECIEVING VACCINE. UPPER EXTREMETIES COLD TO TOUCH, AWAKE AND ALERT X4  TOLERATED ORANGE JUICE SYMPTOMS IMPROVED.
Headache, Tired, Body Aches, Neuropathy in feet and joints, Decreased Cognitive Skills, Memory Loss, Argumentative
Sudden onset lower lip swelling diagnosed as angioedema. No response to diphenhydramine and 10mg of dexamethasone suggesting this was not an IgE mediated allergic reaction. Edema resolved spontaneously several hours after medication trial while en route to ER. Concern for airway compromise high due to irritation and tingling sensation of gums and tongue at onset of symptoms. No prior hx of angioedema.
High fever, full body aches during day following injection  Treated with water, ibuprofen, and rest  All resolved by third day
This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnicity. 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 and expiry: UNKNOWN) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that the patient had to have heart surgery after taking the vaccine and it was also started by the reporter that, "I just had a friend who just had to have heart surgery after taking that stupid shot that not was really even affective all took the shots were the one getting the virus an yaw got sued mega million dollars cause the shot an your talcum powder". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart surgery was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000221486. Sender's Comments: V0 20220325588-COVID-19 VACCINE AD26.COV2.S-heart surgery. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Around 3PM on Saturday March 6, 2021, my right deltoid area became red and swollen with an extremely itchy rash. The area was very warm to the touch. My face was also flushed, but I did not feel feverish. The severe itching continued through Sunday night, lessening on Monday morning. The swelling decreased Monday morning, however, as of today, I still experience occasional itching, the area is still red and the skin feels bumpy to the touch. Monday morning I also experienced vertigo and diarrhea.  This is the first time I have had an adverse reaction to a vaccine.
Within a few hours of shot, developed a fever, arm where shot was given became erythematous from shoulder blade down. The following day had nausea and vomiting.
Dizziness; Body aches; Headache; Chills; Fever; Big rash at the injection site; Warm to the touch at injection site; Tender to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE RASH (Big rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and VACCINATION SITE PAIN (Tender to the touch at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE RASH (Big rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and VACCINATION SITE PAIN (Tender to the touch at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported    Reporter did not allow further contact
pt recvd vax & exp hives shortly a/ or p/2nd dose sometime in JUL; hives lasted 304 months a/subsiding;
No adverse reaction. Reporting due to wrong administration dose. This patient was given pediatric dose of Hep B vaccine (Engerix) instead of the adult dose. Patient was called and recommended another appointment to receive correct dose by clinic physician.
This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (paresthesia on their left side (arms)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 008B21A) for COVID-19 vaccination. Concurrent medical conditions included Osteoarthritis since 02-Jan-2007, Hyperlipemia since 02-Jan-2000 and Actinic keratosis since 02-Jan-1995. Concomitant products included SIMVASTATIN from 02-Jan-2010 to an unknown date for Hyperlipidemia, ACETAMINOPHEN from 02-Jan-2007 to an unknown date, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) from 11-Jan-2020 to an unknown date, CALCIUM CARBONATE from 02-Jan-2000 to an unknown date and COLECALCIFEROL (VIT D3) from 05-Jan-2009 to an unknown date for Osteoarthritis, PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH), MAGNESIUM, FAMOTIDINE and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication. On 16-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jan-2021 at 2:00 PM, the patient experienced PARAESTHESIA (paresthesias on their left side (arms)). On 22-Jan-2021, PARAESTHESIA (paresthesias on their left side (arms)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reportedly, the patient stated experiencing patches of parasthesias 5 to 10 cm in diameter on the skin of her upper arms and legs. These parasthesias gradually subsided after about 5 days. The patient never sought medical attention other than asking her husband, who is a retired family physician. The patient took the second dose on schedule four weeks later, and had no recurrence of the parathesias. Treatment information was not provided by reporter. Action taken with mRNA-1273 was not applicable. This case was linked to MOD-2021-040841. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021. Reporter details was reported. Patient details was reported. Suspect vaccine was updated. Event and outcome was reported. Concomitant medication was reported.
He felt a little sore; Tired for 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (He felt a little sore) and FATIGUE (Tired for 2 days.) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from April 2020 to May 2020, Shingles and Organ transplant. Concurrent medical conditions included Immunocompromised, Sleep disorder and Memory deficit. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes zoster immunisation, MULTIVITAMINS [VITAMINS NOS] and GINKGO BILOBA (GINGKO BILOBA) for Memory impairment, CLONAZEPAM (KLONOPIN) for Sleep disorder.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYALGIA (He felt a little sore) and FATIGUE (Tired for 2 days.). In April 2021, MYALGIA (He felt a little sore) and FATIGUE (Tired for 2 days.) had resolved.            No treatment information was provided.  The patient post receiving their second dose felt a little sore and tired for 2 days. The patient identified their gender as non-binary and was qualified for the 6 month booster shot according to the Department of Health in as the patient had an organ transplant and was immunocompromised.  The patient was taking concomitant medications which included Valtrex, prophylactic or treatment for herpes zoster or shingle, Klonopin to help with sleep and multivitamins and ginkgo to help with memory.   The patient also reported that they had COVID virus which started in April 2020 and ended in May 2020.   This case was linked to MOD-2021-306193, MOD-2021-306228 (Patient Link).
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JAN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # L008057 and expiration date 01-DEC-2016, 2 ml administered orally. No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
ADVERSE EVENT: It was reported to this writer that patient on 4/09/21 at 15:15 hours received the Pfizer Vaccine as his second dose in his Left Deltoid. The guest received his first dose of the Moderna Vaccine on 3/12/21 @16:50 hours ? Right Deltoid.    INTERVENTION/TREATMENT: Consulted with medical provider. Guest was made aware of this incident. Educated on CDC Guidelines. Educated the vaccinator on significance of medication administration to include checking the guests identification against vaccination card to ensure that the correct vaccine is administered. Each start of shift reiterate the need to verify correct vaccine for second dose. Notify POC of any concerns/issues.  OUTCOMES: Guest called with the above information and he states that he is okay. Explain to him that this is not the ideal situation, however he is fully vaccinated and if he has any problems  to follow-up with his Primary Care Provider.
Headache, Myalgia, Fever & Rash Narrative: Fever 102, myalgia, headache, rash on injection arm, Has standing appt with pcp 1/28 and will address any remaining s/s at the time.
Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot (patient received yearly flu shot) and Shingrix with an associated reaction of influenza like illness (patient received 1st dose on an unknown date in 2019 and experienced flu-like symptoms, refer linked case US2021192908).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported but it could be 57 or 58 years old. Two years before the reporting date, the patient had got the Shingix two-shot series and experienced flu-like symptoms for a couple of days. The patient stated that the side effects were expected and had recovered after a day or so. The patient did not specify if side effects occurred after dose 1 or dose 2 or both. The patient did not consent to follow-up and did not want to provide Medical doctor contact information. This case has been linked to US2021AMR193164 and US2021192911, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192908:same reporter,same patient, same suspect, different dose (1st dose) US-GLAXOSMITHKLINE-US2021AMR193164:same reporter US-GLAXOSMITHKLINE-US2021192911:same reporter
Almost 12 hours post vaccine experiencing severe abdominal cramping, similar to menstrual cramping.
24 hrs after vaccination developed low back pain and lower extremity weakness which progressed up to his thighs and had difficulty walking. Was seen in Emergency room, admitted to hospital and received IVIG. Neurologist consult Dx: Guillain Barre syndrome.
A staff member at our office drew up the Pfizer BioNTech Covid 19 5-11 vaccine, without diluting it first. They drew up the correct dose of 0.2 mL, but it was not diluted, thus giving a larger than intended dose. Clinical supervisor//vaccine nurse contacted Pfizer, the ordering provider, point of contact, and the family to notify them of the event. Advised family to watch for localized and systemic reactions. Family will notify the clinic if any redness, swelling, fevers persisting beyond 24 hours, or if any other concerns occur. Clinic will then notify VAERS of any adverse side effect/reactions. At this time the patient is not reporting any adverse side effects.
Redness and swelling at injection (25mg) site (Rt arm). To use BENADRYL and hydrocortisone 1% cream.
Hospitalization for numbness, pain, in hands and feet. IVIG, Narotin. 2/20/09-records received for DOS 11/28/08-presented to ED with C/O hands and feet hurt and tingling and numbness of hands and feet. Symptoms began couple of weeks ago when travelling out of country. DX:Bilateral hand and foot pain, etiology undetermined. Mild Hyperglycemia. 2/26/09-records received for DOS 12/4-12/9/08-DC DX: Post-vaccination demyelinating polyradiculoneuropathy. Presented with numbness and pain in extremities. Treated with IVIG. Nausea vomiting.  Follow-up: Continued nerve pain in hands, feet, continued fatigue. Unable to do physical activity at previous level. Plan to retire earlier due to fatigue. Blood pressure high. Doctor hopes I will continue w/ remyelinization of nerve endings. Doesn't know if I will achieve 100%.
I have vitiligo and am seeing a trigger of increased vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: Fc3182) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vitiligo" (unspecified if ongoing). Concomitant medication(s) included: PROPECIA. The following information was reported: VITILIGO (non-serious), outcome "not recovered", described as "I have vitiligo and am seeing a trigger of increased vitiligo". Therapeutic measures were not taken as a result of vitiligo.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Vitamin multi, Propecia within 2 weeks of vaccination.  The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
ulnar nerve was compromised; tingling and numbness down my arm and in my ring finger and pinkyfinger for a few days; tingling and numbness down my arm and in my ring finger and pinkyfinger for a few days; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 19Apr2021 12:30 (at the age of 41-year-old) as dose 2, single COVID-19 immunisation. Medical history included none. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. Concomitant medication(s) included fluoxetine. On 20Apr2021, the patient experienced ulnar nerve was compromised, tingling and numbness down my arm and in my ring finger and pinkyfinger for a few days. The outcome of all the events was recovered on Apr2021.  No follow-up attempts are possible. No further information is expected.
Eight days after injection a half dollar-sized rash developed at injection site after an intital small red welt had disappearded two days after injection. Treating with antihistamine. Appears less inflamed after two days.
Patient C/O acute (R) arm myalgia, which she contributes to the pneumonia vaccine. Pt. unable to lift affected arm without pain.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 19-APR-2017 to 23-MAY-2017,the patients were vaccinated with improperly stored doses of VARIVAX lot # M005973 with expiration date 02-FEB-2018, lot# M025867 with expiration date 24-MAY-2018 , lot# M033906 with expiration date 20-JUL-2018 (dose and route of administration were not reported). The vaccines were reconstituted with a sterile diluent (lot# and expiration date were not reported) that did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 8 hours. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014497: US-009507513-1705USA014496: US-009507513-1705USA014464: US-009507513-1705USA014495:
On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient stated that she almost died after getting the flu vaccine. Outcome was not reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.Proprietary medicinal product name: Paxlovid. Indication for use in the case: Treatment of COVID-19. Date of start of drug: 07Apr2022. Date of last administration: 05Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.