chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a patient, describes the occurrence of pain in extremity (left arm hurting), back pain (back ache), nausea (nauseous), myalgia (muscle ache) and headache in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030M20A) for COVID-19 immunization. No medical history provided. On May 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 5, 2021, patient experienced back pain (back ache), nausea (nauseous), myalgia (muscle ache) and headache. On an unknown date, patient experienced pain in extremity (left arm hurting). The patient treated with Tylenol (paracetamol); ongoing since an unknown date at an unspecified dose and frequency. On May 8, 2021, pain in extremity (left arm hurting), back pain (back ache), nausea (nauseous), myalgia (muscle ache) and headache resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or concomitant medication. Reporter did not allow further contact.
A report has been received from a pharmacist concerning an 81 year old male patient. Relevant medical history or concomitant medication was not reported. On 26-Sep-2014 the patient started therapy with FLUMIST QUADRIVALENT (intranasal). The patient was over the age of 49 years and has been administered FLUMIST QUADRIVALENT. No adverse effects were observed. The action taken of FLUMIST QUADRIVALENT was unknown. The outcome of the event of inadvertent administration was unknown. The report was considered to be non-serious by the reporter.
High fever (actual temp not recorded), inflammation at injection site, bloody nose-reported by pt.'s mother, states nose bled on lasted short time and other sx a few hours.
Chills, fever over 100, body aches, tiredness, fatigue, injection site pain, feeling unwell, nausea
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and citric acid + corn syrup + quinine + water (Tonic Water). On 12th August 2018, the patient received the 2nd dose of SHINGRIX. On 13th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue. In August 2018, the patient experienced feeling hot, pruritus, erythema and swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fatigue was recovered/resolved and the outcome of the feeling hot, pruritus, erythema and swelling were not recovered/not resolved. It was unknown if the reporter considered the fatigue, feeling hot, pruritus, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: In early June 2018, the patient received 1st dose of SHINGRIX (for tolerance to 1st dose refer linked case US2018GSK153574). The patient was drinking a lot of tonic water, prior to getting the shot (24 ounces of tonic water everyday), as recommended by her physician. The patient waited for more than 2 months between doses. Less than a day after receiving SHINGRIX, the patient experienced swelling, heat, redness and itching close to the injection site. The patient said that it was not exactly where she got the injection, but slightly below, like three inches below her band aid from the shot. The patient also felt wiped out with fatigue on the following day after receiving the injection with both injections. The noticed that her symptoms were heightened, as they seem to linger a long time. The patient wonders if tonic water might interact with SHINGRIX. The patient wanted to report these observations in case other people notice the same thing. This case has been linked with US2018149466 and US2018GSK153538, reported by the same reporter.
Bell?s Palsy started the following Sunday on right side.  Still has on right and this last Saturday has become bilateral.   She was seen at ER  for confirmation and this weekend had a CT/MRI and Spinal tap.  They initially said it was guillain barre but they now think it's just B/L Bells
SWELLING/REDNESS/PRURITUS OF LT ARM 2 DAYS AFTER VACCINATION.  REDNESS AND SWELLING EXTENDED TO FOREARM
Dizziness, nausea, shakiness to the point of extreme difficulty with mobility, excess sweating, pinching pain in left fore arm
Migraines Upset stomach, diarrhea, ovarian cramps, body chills, aches, mild fever
Felt she had a bad flu after the 2nd dose; Was sick within 24 hours after getting the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt she had a bad flu after the 2nd dose) and ILLNESS (Was sick within 24 hours after getting the 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not have any COVID-19 diagnosis prior to or after getting the vaccine.  Previously administered products included for Product used for unknown indication: Flu vaccine (6 weeks prior to getting the 1st booster dose of the Moderna Covid-19 vaccine.) in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Glaucoma (Glaucoma suspect), Food allergy, Seasonal allergy and Allergy to animal (whenever she plays with cats.). Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, LATANOPROST (XALATAN) for Glaucoma.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Felt she had a bad flu after the 2nd dose) and ILLNESS (Was sick within 24 hours after getting the 2nd dose). At the time of the report, INFLUENZA (Felt she had a bad flu after the 2nd dose) outcome was unknown and ILLNESS (Was sick within 24 hours after getting the 2nd dose) had resolved.            It was reported that after 2nd dose patient had a bad flu and was sick within 24 hours and at 5:00pm on the same day she felt sick and when she woke up at 3:00am the next day, she felt fine. No treatment details were reported.  After the 1st booster dose, she felt nothing.   This case was linked to MOD-2022-535460 (Patient Link).
One week after started with Shortness of breath, Chest pain, tachychardia, heart fluttering, pounding heart
Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 (Lot number 662599/1076X). The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 from fevers of 102F to 103F and cellulitis." Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 was given". At the time of the report the patient's outcome were not reported. The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital. The other patients sought medical attention at the physician's office. Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 that caused patient reactions in the office. Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 in the past but had never had reactions such as this in their office". Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 (Lot number not specified). On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23. This is one of several reports received from the same source.
(L) deltoid red, swollen. Hot to touch, itches began 2 days post vaccinating - treatment BENADRYL.
Information has been received from a health professional concerning a 71 year old, white, male reported weight was 158 pounds (lb) and whose reported height was 5"9", who on 25-OCT-2005 at 10:30 am in the doctor's office was vaccinated intramuscularly in the right (Rt) deltoid muscle with PNEUMOVAX 23 vaccine (lot#647661/0055R).  It was reported that the patient had not received any prior doses of PNEUMOVAX 23 vaccine.  On 26-OCT-2005.  It was reported the patient experienced pain to arm, severe redness, edema to injection site for approximately 2 to 3 days post inoculation.  It was reported the patient recovered on 29-OCT-2005.  Additional information has been reported.
Sore arm, body aches, diarrhea, headache, sweating, stomach ache onset 3-4 days after vaccination. Symptoms lasted 3-5 days. Symptoms then returned 1 week later.
10/28/21 presents to EC ED as a transfer from OSH for SOB, COVID + and elevated troponin on heparin gtt. PMHx of renal transplant (2005), 2/2 lupus nephritis, Afib, DM II, neuromyelitis optica with paraplegia below the waist, non-Hodgkin's lymphoma.
This literature marketed information has been received from a published literature article title as stated above and refers to a 13-year-old boy with known beef, pork, and milk allergy who in approximately 2009, experienced a large local reaction from the injection site on the thigh to the toes after VARIVAX (vaccination date, dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. The patient was diagnosed as an allergic reaction by treating physician. At the time of reporting, the outcome of the allergic reaction was unknown. The reporter considered the allergic reaction related to VARIVAX. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012067, US-009507513-1809USA012063,US-009507513-1809USA012064, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156:
Pt states that about 12 hours Tdap immunization she was having dinner, felt very nauseated, dizzy, tunnel vision, cold sweats.  Pt sat down for about 10 minutes and felt better.  Then about 1 hour later, pt felt very cold, had chills.  Pt states that she woke up repeatedly during the night with sore muscles.  Pt states that she now feels fine.
I woke up early the morning following the vaccine with pain in my left hand.  It was hugely swollen and I could not bend my fingers.  I went into the bathroom and found the the left side of my face and my left eye were black and blue.  The hand then turned black and blue.    Today is day 5 following the vaccine and the hand and eye are only marginally better.  As background, a year ago I had a benign lipoma cut out on my face, left side just above the brow.  The face looked identical then as now.  About 18 months ago I had surgery on the left hand to correct a trigger thumb.  Again, the hand then looked exactly like it does now.  On day three after the vaccine, a knee replacement scar on my right leg had turned purple.  No bruising nor sensitivity anywhere else on the knee--just along the line of the scar.  That surgery was 10 years ago.  Unlike the other surgical sites, it has now returned to normal flesh color.
04/15/2003 @ 2200 injection site became swollen and itchy.  04/16/2003 @ 0730 swelling spread to upper arm towards shoulder down to above the elbow.  Patient saw Dr. 04/17/2003, patient given Allegra and Dicloxacilin.
Information has been received from a registered nurse concerning 2 approximately 18 year old females with no pertinent medical history or drug/allergies who in approximately May 2007 "about a month ago" were vaccinated with the first dose of GARDASIL, IM. There was no concomitant medication. The patient's got very lightheaded after receiving the vaccine. The patient's were instructed to lay down. Medical attention was sought. The patient's recovered from the event that same day. Additional information has been requested. This is a follow-up to reports previously submitted on 10/8/2007. Information has been received from a registered nurse concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on 23-MAY-2007 "about a month ago was vaccinated with the first dose of GARDASIL (lot# 657617/0384U). IM Concomitant therapy included "birth control pills" hormonal contraceptives (unspecified). On 23-MAY-2007 after being vaccinated. The patient became pale and she was laid back in the chair. The patient was very pale and weak but she did not faint. The patient was treated with ice that was applied to her forehead and neck. She was monitored for approximately 15 minutes. The patient felt fine and left the physician's office. The nurse considered the events as non-serious and related to therapy with GARDASIL.
Brief fainting, jerking (once) with 5 minutes after shots. Treatment: cold compress, lying down, elevate feet.
Information regarding PREVNAR was received from a healthcare professional regarding a 7-year-old female patient who experienced pneumococcal titer levels all very low except for 23F.  The patient received the second dose in 2001.  Relevant medical history was not provided.  Product was administered in 2001.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  On unspecified dates in or around 2001, the patient received a dose of PREVNAR at 13 months and 15 months of age.  On an unspecified date in or around 2007, at 7 years of age, the patient's pnuemococcal titer levels revealed that all but 23F were very low (antibody test abnormal).  The reporter noted the patient is 'continually ill' (malaise).  The patient's outcome is unknown.  Antibody test (results: pneumococcal titer levels all very low except 23F) was done in 2007.  No additional information was available at the time of this report.
Patient received Pfizer covid vaccine shot on 5/13/21.  Patient reported feeling hot and sweaty. Patient subsequently fainted. Patient reports that she had fainted in the past when she received a steroid injection at a different facility. Patient recovered from fainting and she reports feeling much better.
Menstrual Cycle Normally I have a very mild 3 day period.  In February my period was a week and much heavier.  March brought on a very heavy 2 week period.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more).    Concomitant medication was not reported.  Vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more. Vaccine was given within current guidelines except seven were under 65. Patients were treated for skin lesions, brain, systolic blood pressure 220, Tachycardia greater than or equal to 150 and body aches. Treatment medication was not reported.  This case contains information of 15th out of 42 reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Administrated / after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2023) for prophylaxis.   On 23rd July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164789:Same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164801:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:Same reporter. US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:Same reporter. US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164800:Same reporter. US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164786:Same reporter. US-GLAXOSMITHKLINE-US2021164794:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164804:Same reporter. US-GLAXOSMITHKLINE-US2021164805:Same reporter. US-GLAXOSMITHKLINE-US2021164806:Same reporter. US-GLAXOSMITHKLINE-US2021164808:Same reporter.
sore; Being achy in joints; being achy in joints and some muscles; fever spike to 103.4F; headache; No appetite; mild coughing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), COUGH (mild coughing), PAIN IN EXTREMITY (Sore arm), PAIN (sore) and ARTHRALGIA (Being achy in joints) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by reporter.  Concurrent medical conditions included Hypothyroidism since 23-Jan-2015. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 23-Jan-2015 to an unknown date for Hypothyroidism, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), COUGH (mild coughing), PAIN (sore), ARTHRALGIA (Being achy in joints), MYALGIA (being achy in joints and some muscles), PYREXIA (fever spike to 103.4F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 16-Mar-2021 at a dose of 2 dosage form in total. On 05-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DECREASED APPETITE (No appetite), COUGH (mild coughing), PAIN (sore), ARTHRALGIA (Being achy in joints), MYALGIA (being achy in joints and some muscles), PYREXIA (fever spike to 103.4F) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood immunoglobulin G: unknown (Positive) IgG positive. On 16-Mar-2021, Body temperature: 103.4 (High) 103.4 F. On 16-Mar-2021, COVID-19: unknown (Negative) COVID-19 negative. On 16-Mar-2021, Influenza virus test: unknown (Negative) Flu test negative. On 16-Mar-2021, Polymerase chain reaction: unknown (Negative) PCR negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26MAY2021, included patient demographic details, lab data  and medical history details.
I tested positive for COVID-19. I have fatigue; slight headache off and on ,and a little cough. I had a telehealth visit and they prescribed me Paxlovid. I also have a metallic taste from the Paxlovid.
Sore arm first two days. No reactions next 5 days. Red rash at injection site 7 days later beginning in the middle of the night . 4x4 red swollen itchy area next two days. Delayed reaction cleared by 1/25.
This spontaneous report was received from a Licensed Practical Nurse refers to 24 patients of unknown age and gender. On an unknown date the patients were vaccinated improperly stored doses of (Merck) VARIVAX, 0.5 ml, subcutaneous (lot # was not reported). No adverse effect reported. Additional information has been requested.
Had vaccine at about 320pm on 10/25/2021. The following morning, had lower abdominal cramping and diarrhea.  Later in the day, developed low back pain, chills and started with vomiting at night.  Tactile temperature.  Otherwise, resolved today 10/27/2021.  Did have frozen chicken nuggets the night before
Dizziness since 2nd dose; Vertigo since 2nd dose/Head is spinning after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness since 2nd dose) and VERTIGO (Vertigo since 2nd dose/Head is spinning after 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness since 2nd dose) and VERTIGO (Vertigo since 2nd dose/Head is spinning after 2nd dose). At the time of the report, DIZZINESS (Dizziness since 2nd dose) and VERTIGO (Vertigo since 2nd dose/Head is spinning after 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported for Dose 2 Events.   This case was linked to MOD-2021-106416 (Patient Link).