chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was raised; Injection Site Red Edematous Rash; Red edematous rash; slight itchiness at the injection site; A spontaneous report was received from a health care professional concerning a 24-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced slight itchiness at the injection site and red edematous rash, slightly raised.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 037K20A) intramuscularly in her left arm for prophylaxis of COVID-19.  On 02 Jan 2021, the patient experienced a slight itchiness at the injection site.   On 03 Jan 2021, the patient woke up with a red edematous rash, slightly raised.  The patient stated that the redness was less in the center, but the area had spread to 110 mm. c, red, not itchy, not painful. Treatment included diphenhydramine hydrochloride, taken three times.   The outcome for the events, slight itchiness at the injection site, red edematous rash, slightly raised, were unknown.; Reporter's Comments: Based on the established safety profile and a temporal association between the reported events of slight itchiness at the injection site, red edematous rash, slightly raised, and administration of mRNA-1273 vaccine, a causal association cannot be excluded. The events of injection site pruritus, injection site induration , injection site rash and injection site erythema are consistent with the product safety profile.
Vaccine was exposed to storage temperatures outside the recommended ranges. Patient did not need any treatment and did not have any symptom.
Patient experienced rapid heart rate starting on May 25, 2021.  I took him to the ER on May 26, 2021.  They tried a couple of different methods to get his heart rate back to normal and were finally successful after shocking his heart.  They administered several tests to find out why his heart rhythm had been so fast.  They diagnosed him as having acute idopathic myocarditis.  He was placed on Metoprolol for 3 months and fitted for a Life Vest that he wore for 30 days.  On June 28th, patient had another MRI and it showed that the myocarditis was reduced.  He continued with the Metoprolol.  On September 3rd, he took a heart stress test, and was allowed to go off of the Metoprolol.
Had an extremely high fever of 103.4 about 28 hours after the vaccine. Fever was not brought down by Motrin/Tyelenol.  Also shaking chills.
Red warm area about 4 x 2.5 cm with sl larger induration plus supraclavicular & lower out cervical nodes mild body aches.
I lost my sense of smell and my sense of taste; I lost my sense of smell and my sense of taste; This is a spontaneous report received from a contactable nurse (consumer). A 68-year-old patient (same age at vaccination) female received second dose of bnt162b2 (BNT162B2, Solution for injection, lot: ER2613) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history reported was high blood pressure, osteoporosis , chronic UTI and high cholesterol . Concomitant medications reported was Omeprazole 40 mg (once daily), Losartan as 100 mg once daily, Atenolol as 25 mg one daily, Oxybutynin as 5 mg daily, Rosuvastatin as 10 mg daily, acetylsalicylic acid (ASPIRIN) as 81 mg daily, estradiol (ESTRACE, cream) as 2 times a week, alendronate sodium (ALENDRONATE SODIUM) as 70 mg weekly , vaccinium macrocarpon (CRANBERRY) as once daily, Multivitamin daily and Calcium as 600 mg twice a day. The patient previously took first dose of BNT162B2 (lot number EN6198) on 02Mar2021. Patient reported lost of her sense of smell and my sense of taste. Retired nurse stated she believed that it was caused by the vaccine. Retired Nurse stated Let me get my card right now, you want both doses okay my first dose was lot number EN6198 and the second one the lot number was ER2613. It was reported. Patient was still experiencing the events. No treatment was received by patient in response to the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Flu like symptoms; headache; fever; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 25Mar2021 at 09:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: unknown), via unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced flu like symptoms, massive headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events flu like symptoms, massive headache and fever was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
~24 hrs from injection, developed low grade fever progressing to 102 degrees later that day (30 hrs post injection). Body aches, fatigue, and a very swollen axillary lymph node. Same side as the COVID vaccine.
I developed a "Cellulitis " type reaction from ankle  to 2-3 inches above ankle. Also other spots appeared on legs especially and arms as well.
Fussy, inflammation to rt arm shoulder-localized 3" diameter arm checked by MD;
This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. On 26-APR-2013 the patient was vaccinated with GARDASIL dose 3, 0.5 ml. The patient received her second dose of GARDASIL two years ago and was in the office to receive her third dose. No adverse effects reported. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-FEB-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed VALTREX, gabapentin and a lidocaine patch for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vaccine was administered around 0830 hours on 11/08/17. At around 2330 that night I awoke with the chills, entire body aches, nausea, and pains. I fell back asleep and awoke around 0330 the next morning drenched in a cold sweat. I felt the chills, body aches, nausea, and pains until I woke up on 11/10/17 at which time I felt fine.
Left deltoid still aches with muscle spasms, stretches helps the ache; Left deltoid still aches with muscle spasms, stretches helps the ache; eczema on my forearms have noticed an increase in outbreaks; nodules under the skin/still have a noticeable lump in my left deltoid; have sporadic patches of skin on left arm that sting / stinging skin; sporadic patches of skin on left arm that sting and hurt to the touch; This non-serious case was reported by a consumer and described the occurrence of muscle spasm in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF) for prophylaxis.   Concurrent medical conditions included blood pressure high, type ii diabetes mellitus and arthritis. Concomitant products included loratadine (Claritine), paracetamol (Tylenol), semaglutide (Ozempic), valsartan and fluticasone propionate (Flovent Diskus).   On 07-DEC-2022, the patient received Shingrix .5 ml. On 19-JUL-2023, 224 days after receiving Shingrix, the patient experienced skin nodule (Verbatim: nodules under the skin/still have a noticeable lump in my left deltoid), stinging skin (Verbatim: have sporadic patches of skin on left arm that sting / stinging skin) and patchy rash (Verbatim: sporadic patches of skin on left arm that sting and hurt to the touch). On an unknown date, the patient experienced muscle spasm (Verbatim: Left deltoid still aches with muscle spasms, stretches helps the ache), muscle pain (Verbatim: Left deltoid still aches with muscle spasms, stretches helps the ache) and eczema (Verbatim: eczema on my forearms have noticed an increase in outbreaks). The outcome of the muscle spasm, eczema, skin nodule, stinging skin and patchy rash were not resolved and the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the muscle spasm, muscle pain, eczema, skin nodule, stinging skin and patchy rash to be related to Shingrix.     It was unknown if the company considered the muscle spasm, muscle pain, eczema, skin nodule, stinging skin and patchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2023 The reporter was a patient. The patient still had a noticeable lump in her left deltoid, had sporadic patches of skin on left arm that sting and hurt to the touch. The reporter reported that the left deltoid still aches with muscle spasms, stretches helps the ache, but nothing helps the stinging skin. The patient also had eczema on her forearms and have noticed an increase in outbreaks and nodules under the skin. The reporter gave a permission to contact.
a 11 year old patient received a dose of Flublok Quadrivalent/No AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer (pharmacy-other).  This case is considered as non-valid as patient identifier was not reported.  This case involves a 11 years old patient (gender unknown) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] VACCINE lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Information on the batch number was requested.
Redness, swelling, warmth at injection site. Hive-like. Lasted 2-3 days. Pt. became febrile and was seen for office visit. S/S resolved.
Received Moderna vaccine on 12/29/2020.  12/30/2020 fever of 100.4 Tylenol given and monitored and fever went down.  12/31/2020 Chest x-ray completed and sent to the hospital and admitted with pneumonia.  1/3/2021 reported by the hospital that Covid-19 results were positive.  He had had Covid-19 positive results back on 11/4/2020 prior to vaccine.
patient had an unspecified reaction after being administered a dose of GARDASIL 9; This spontaneous report was received from a physician via a company representative and refers to a male patient currently 17 years old. There was no information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided.  On 20-AUG-2018, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# N020353 with expiration date on 28-APR-2020, exact dose frequency and route of administration were not provided).   On an unknown date, reported as after being administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient experienced an unspecified reaction. The outcome of the event was unknown. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was not reported.  Lot number was reported in the source document, but the expiration date was not. But, when entering the lot number in MARRS the system automatically auto-populated the expiration date.  This is one of several reports received form the same reporter.; Sender's Comments:  US-009507513-1905USA011106: US-009507513-1905USA011668:
Started with insomnia and body aches. Started swelling from feet up to chest area, engorged pubic area lower abdomen  veins.  ER visit 11/30/2021 - prescribed Lasix 20 mg and removed 19 pounds of fluid.  2nd ER visit 01/21/2022. Will see a Dr on 01/24/2022
w/in 4 hrs p/DTP pt exp an inject site rxn (rt thigh); pt had swelling & induration (2 1/2 in diameter); pt was unable to walk; seen in office on following day; tx included warm compresses & APAP;
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.
Extremely swollen left upper arm (quad area) and bright red (like a sunburn)... started 8/15 gone by 8/21.
Skin rash over right upper thigh and buttocks; This is a spontaneous report from a contactable male consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 23Feb2021 10:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunization at public health clinic/veterans administration facility. The patient medical history was not reported. The concomitant medications included atenolol (ATENOLOL), simvastatin (SIMVASTATIN, lisinopril (LISINOPRIL), and hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient had no allergies. 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, the patient had not been tested for COVID-19. On 27Feb2021 14:00, the patient experienced skin rash over right upper thigh and buttocks. The patient did not receive any treatment for the event. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
8PM 7NOV94 noted hives on hands, bra line, hips, waist, when shoes tied, behind ears, in hair, hands swollen;
Case number PHEH2015US026960, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 29-year-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 29 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, a 2-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes; additionally on 26-MAY-2022 experienced an additional temperature excursion of 35.2 F for 56 seconds. If a digital data logger was involved was not reported (product storage error) (product storage error).   Consequently, on unknown dates 31-MAY-2022, the patients was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
Following 1st dose vax experienced pain @ inject site; Following 2nd dose prolonged pain & tenderness @ inject site;
dizzy; weakness/feels so weak; feels sleepy all day long; Dry mouth; knocked him off balance; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101467586.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: 302030A) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, first two shots that he took 6 or 7 months ago), administration date: 2021, when the patient was 69 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, first two shots that he took 6 or 7 months ago), administration date: 2021, when the patient was 69 years old, for Covid-19 immunization.  The following information was reported: ASTHENIA (non-serious) with onset 23Oct2021, outcome "not recovered", described as "weakness/feels so weak"; SOMNOLENCE (non-serious) with onset 23Oct2021, outcome "recovering", described as "feels sleepy all day long"; DRY MOUTH (non-serious) with onset 23Oct2021, outcome "recovering", described as "Dry mouth"; BALANCE DISORDER (non-serious) with onset 23Oct2021, outcome "recovering", described as "knocked him off balance"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  No follow-up attempts are possible. No further information is expected.
ADMINISTRATION OF 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 28 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: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced administration of 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219686, 20211219701, 20211219807 and 20211219871.
Erythema, edema to left arm. Whelps throughout body area. Symptoms began morning after injection. (7/12/12) Saw MD on 7/12/12; Symptoms improved - 7/16/12.
Very very severe menstrual cramping, heavy bleeding with clots.; Very very severe menstrual cramping; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 17Sep2021 at 11:30 AM (Batch/Lot number was not reported) (at the age of 54-year-old) as dose 1, single for COVID-19 immunization. Facility type vaccine was pharmacy or drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant. The patient's medical history included allergies to penicillin and shellfish. Concomitant medications included estradiol, progesterone (PROGESTIN), ascorbic acid (VITAMIN C), vitamin D NOS (VITAMIN D), and probiotic; all taken for unspecified indications, start and stop dates were not reported. On 18Sep2021 18:00 (06:00 PM), the patient experienced very very severe menstrual cramping, heavy bleeding with clots. The patient was not tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Information has been received from a physician concerning a 14 year old female who in mid July 2007 was vaccinated with her first dose of Gardasil. The patient did not completely faint because someone caught her before she hit the floor. The physician reported that after receiving her second dose of Gardasil the patient was fine. On approximately 15-JAN-2008 the patient received her third dose of Gardasil via injection and the patient developed severe myalgia and had a temperature of 102 degrees Fahrenheit. The physician reported that the patient was given a bunch of tests for viruses, but all the tests came back negative and the patient recovered the day after receiving the third dose. Additional information has been requested.
Tested positive for COVID on 15 Nov 2021, almost 8 months after second vaccination.