chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In September of 2014, I received the first GARDASIL vaccine. Within a month I began developing unexplained symptoms. I saw my doctor in November 2014 and was diagnosed with chronic hives of unknown source. Also, I began experiencing muscle, nerve and joint pains, sensitivity to touch, extreme weight gain and purple striae. I was unable to get the hives under control with medications and began seeing an allergist who stated it was something autoimmune that had been triggered and it wasn't anything environmental causing the hives. I obtained a second opinion and they had stated the same thing. I had seen endocrinology, allergy/immunology, neurology, rheumatology and several general practitioners who all could not and still cannot find a cause for the development. I now have to be injected with several thousand dollar injection to control the hives and still have to take an antihistamine. My mother had done research and found articles stating the GARDASIL had unlisted side effects, one including an autoimmune disorder. Also, I was speaking with a coworker whose niece had the same problem but worse. My hives are triggered by anything, heat/cold, touch, pressure, lotions, etc. I still have not been able to lose the weight and swell up at times, so badly I can barely bend my neck. My eyes are constantly itchy and swollen and I had never had allergies or pain before this. I also was 120 pounds and gained 30 pounds within the few months of receiving the vaccine without making any changes.
Rash, redness, itchy, burning Temporary, vanishes upon application of cortisone gel or time,  reappears at a different spots minutes to hours later.
June 26, 2002 evening: fever 102 F at 10pm, some redness, swelling, and tenderness left deltoid (prevnar) mild redness, swelling right deltoid (Trihibit). Rx: Ceftnoxone IM and Augmentin 250 mg po bid.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 47 years old female patient who experienced rash is raised, slightly elevated, itches, and red when she scratched it and red when she scratched, while she received vaccine FLUBLOK QIV. The patient's past medical history and concomitant medications were not provided. On 06-Sep-2018, the patient received a single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in the left arm. On an unknown date, the patient developed a non-serious rash a week after vaccination, rash was raised, slightly elevated following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious itches, and red when she scratched it following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious red when she scratched following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Patient was given a steroid injection to help with the inflammation, name not known and they took blood work. Patient was given another shot, put on a Prednisone taper and an H blocker (name not known). Patient underwent patch testing. (Other relevant tests included Patient receive a Tuberculosis test, name not known, the same day it came back negative). Final diagnosis was red when she scratched, itches, and red when she scratched it and rash is raised, slightly elevated. As lab test, patient did receive a TB test, name not known, the same day that came back negative. The patient outcome is reported as Unknown for rash is raised, slightly elevated, as Unknown for itches, and red when she scratched it and as Unknown for red when she scratched.
Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, on 06Jan2021 at SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included BNT162B2, intramuscular from 16Dec2020 to 16Dec2020 (1st dose; lot: PAA156051). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no concomitant medications. The patient experienced pain at injection site, body aches and headache. The outcome of event was recovering. No treatment received.   No follow-up attempts possible. No further information expected.
My son began having a fever and respiratory symptoms on 5/12. I took us both to be tested for Covid. My rapid test came back negative on 5/12. On 5/13 I was having a mild retro orbital headache with no fever or other symptoms and I received notification that my PCR test had come back positive. Over the weekend, I developed nasal congestion and a fever that got up to 100.3 and some sever fatigue that caused me to sleep most of the weekend. By Tuesday, I was feeling a little short of breath and my doctor emailed to inform me that she felt that I would benefit from a Paxlovid prescription which I began on 5/17. By 5/19 I had developed a sore throat, congestion, and a mild cough with persistent fatigue. Over the next few days my symptoms have began to improve.
Patient developed diffuse itchy hives and swelling of the upper lip, R eye, and R ear. Mom gave benadryl at home and then brought patient to urgent care, where patient received oral prednisolone. Patient was then sent home to complete 5 day course of oral prednisolone. Mom has continued to give patient oral benadryl and topical benadryl as needed, with improvement in sypmtoms.
vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). The patient was treated with PENICILLIN NOS for Vertigo, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). The patient was treated with PENICILLIN NOS for Vertigo, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.
10/1 had a fever then on 10/3 developed a rash. Went to the ER on 10/7 in which she was given 60mg of Prednisone on 10/8 her MD wrote for a 7 day rx of prednisone 20mg tab qd
Rash developed around the injection site, which was on her left thigh, and then spread to the rest of her left leg.  Within days it spread to her left side of abdomen, left arm and slowly spread to her right side as well, although less pronounced on her right side. So far, it has not spread to feet, hands, or face.
Metal taste  under tongue starts about 30 seconds after injection. At the beginning, the metal taste was strong, but gradually disappeared in three to four hours. The tip of tongue started to feel tingling, numb within two hours, the symptoms are gradually improving. The tip of  tongue also felt swollen within three to four hour, but improving. The pain on the injection site was getting worse in two to three hours, but stable  for next twenty hours.
On 6/8/2021, he developed numbness on chest, back fingers and toes.  By 7/8/2021, symptoms had improved with mild residual paresthea in fingers and teos.  On 8/5/2021, he developed numbness in right lower limb.  On 8/6/2021, right leg became weak, and balance was impaired.  He also developed superficial pain in chest and abdomen.  By the time of visit in neurology clinic 11/16/2021, most symptoms had resolved, but abnormal sensation in left foot has persisted.  MRI brain, C spine and Ts spine w and w/o contrast 11/24/2021 showed two T2 hyperintense lesion in spinal cord, one at C2 and T1-2.
This case was reported by a consumer via call center representative and described the occurrence of difficulty thinking in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 months ago from reporting date, refer case US2019GSK033538). Concurrent medical conditions included balance difficulty (Balance issues due to age and arthritis.). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th February 2019, less than a day after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), influenza-like symptoms, pain in arm, general body pain and queasy. On 18th February 2019, the patient experienced papular rash. Rechallenge with SHINGRIX was positive. On 16th February 2019, the outcome of the difficulty thinking, influenza-like symptoms, general body pain and queasy were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the papular rash was unknown. It was unknown if the reporter considered the difficulty thinking, influenza-like symptoms, pain in arm, general body pain, queasy and papular rash to be related to SHINGRIX. Additional details were received as follows: In the morning, the patient received SHINGRIX in left arm. Around 2:00 pm, his arm began to hurt. The patient developed flu like symptoms, including body aches and pains, queasiness, and he could not think. The patient was afraid he would fall in the hall because he already had balance issues due to his age and arthritis prior to receiving the SHINGRIX vaccine.   In the next morning, he felt fine. There was still some soreness in his left arm where he had the dose.   On the day of reporting, in the morning, 3 days after vaccination, the patient noted a cluster of 5 to 6 bumps under his right breast, some were more prominent. They did no not hurt or itch. The patient did not consent to follow-up.
She feels like she is having migraine right now; She feels nauseous; She has stomach upset.; She is having stomach cramps; At midnight, she woke up with sweats; Chills; Her temperature was 99.3; Her head was hurting so bad at midnight so she used ice packs.; Her ear drums were hurting; On same day at night, she had a really sore left arm(injected arm); it went up to shoulder/ now pain is radiating to neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)), PAIN (it went up to shoulder/ now pain is radiating to neck), MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous) and ABDOMINAL DISCOMFORT (She has stomach upset.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Levothyroxine 50mcg.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)) and PAIN (it went up to shoulder/ now pain is radiating to neck). On 30-Apr-2021, the patient experienced MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous), ABDOMINAL DISCOMFORT (She has stomach upset.), ABDOMINAL PAIN UPPER (She is having stomach cramps), HYPERHIDROSIS (At midnight, she woke up with sweats), CHILLS (Chills), PYREXIA (Her temperature was 99.3), PAIN (Her head was hurting so bad at midnight so she used ice packs.) and EAR PAIN (Her ear drums were hurting). At the time of the report, VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)), PAIN (it went up to shoulder/ now pain is radiating to neck), MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous), ABDOMINAL DISCOMFORT (She has stomach upset.), ABDOMINAL PAIN UPPER (She is having stomach cramps), HYPERHIDROSIS (At midnight, she woke up with sweats), CHILLS (Chills), PYREXIA (Her temperature was 99.3), PAIN (Her head was hurting so bad at midnight so she used ice packs.) and EAR PAIN (Her ear drums were hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment: Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-099513 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099513:case for wife
vaccine was stored in the freezer instead of the fridge and was administered to the patient. No adverse reactions have been reported.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus three neonate patients developed sepsis. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Upon internal review, company assessed the event of sepsis and vaccine exposure in utero as serious and important medical event. Documents held by sender: none.
Red, itchy, swollen, hard and hot spot where injection was given... About 2 inches in diameter.
whiplash; Injection site bruises; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection site bruises) and POST-TRAUMATIC NECK SYNDROME (whiplash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Injection site bruises). On an unknown date, the patient experienced POST-TRAUMATIC NECK SYNDROME (whiplash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Injection site bruises) and POST-TRAUMATIC NECK SYNDROME (whiplash) outcome was unknown.
I immediately felt extreme dizziness following vaccination which lasted strong 4-6 hours after vaccination. Two days later I am still feeling unbalanced. I also felt heart palpitations shortly after and extreme chest pain akin to a heart attack. When it did not subside, I went to urgent care and was diagnosed with Costochrondritis.
a low grade fever began 24 hours after injection with 1" swelling at injection site fever slowly climbed for three days peaking at 103 degrees F around 5 days after injection 101-103 degree fever lasted 3 days temperature dropped back to 99 degrees F 6 days after injection
ARM PAIN THAT SHE RECEIVED THE VACCINE, PAIN WAS TERRIBLE AND RADIATES TO THE SHOULDER (UP TO THE NECK) AND IT'S MUSCLE; MUSCLE ON THE ARM GOT HOT; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 076C21A, and expiry: UNKNOWN) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced muscle on the arm got hot. On 11-NOV-2021, the patient experienced arm pain that she received the vaccine, pain was terrible and radiates to the shoulder (up to the neck) and it's muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain that she received the vaccine, pain was terrible and radiates to the shoulder (up to the neck) and it's muscle, and the outcome of muscle on the arm got hot was not reported. This report was non-serious.
Had severe burning in right shoulder centering around the injection site. For two week could not raise right arm past 90 degrees. Have had pain in the right shoulder and upper arm with extreme numbness in the upper are area. The right shoulder blade area has developed severe atrophy which as caused major weakness in right arm/shoulder area. Being right handed this as limited my ability to so daily functions and has affected my ability to perform certain functions at my workplace.
Mixed mRNA vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed mRNA vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed mRNA vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed mRNA vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of (Product storage error  Product administration error  for mRNA-1273, lot #   with no associated Adverse Events.
adverse reaction to Moderna vaccine; felt very heavy; felt very dizzy; Covid arm for 2 days; feel light headed even when I was in shower; felt ill for about a week; fever was 102degF; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days) and DIZZINESS (feel light headed even when I was in shower) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days), DIZZINESS (feel light headed even when I was in shower), MALAISE (felt ill for about a week) and PYREXIA (fever was 102degF). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days), DIZZINESS (feel light headed even when I was in shower), MALAISE (felt ill for about a week) and PYREXIA (fever was 102degF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Lots of fluid and Gatorade   This case was linked to US-MODERNATX, INC.-MOD-2021-049707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049707:
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (lot # L004741, expiration date 04-MAR-2017; lot # L006547, expiration date 04-MAR-2017; lot # L048237, expiration date 08-MAY-2017; lot # L014415, expiration date 25-JUL-2017 and lot # L016429, expiration date 09-AUG-2017) (dosage, strength and route unknown) (temperature: -10 degree Centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles)). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 46 year old female patient who yesterday on 18-JUN-2013, was vaccinated with a dose of PROQUAD (Merck) (dose and lot number not reported) due to human error. No adverse effect was reported. Additional information has been requested.