chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On  1/29, my vision blurred and I could not read the computer e-mails and there were wavy lines in my peripheral left side vision.  My blood pressure sky rocketed to 190/82 and I am always in the 120s over 70s or so.  I went to the ER where I was given an EKG, a head CT scan, blood work was also done.  Next day I had an MRI of my head.  All was done to rule out a TIA.    Final diagnosis was probably an Ocular Migraine which I have never had.  I followed up with an eye doctor who said my eyes were fine.    Whether this was coincidental or a reaction to the Covid shot, no one could tell me.  I felt fine next day and have not had any other ocular migraines.
UNEXPECTED THERAPEUTIC BENEFIT (HAVE NOT HAD AN OUTBREAK (HERPES AND SHINGLES); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: terrible, horrific cold sores (literally no exaggeration), and shingles, and other pre-existing medical conditions included: The patient had cold sores and shingles outbreak occurred up to 3 times a year. The patient had indescribable pain, itch, fever, chills due to shingles and had received shingles shot series. The patient was previously treated with valaciclovir hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced unexpected therapeutic benefit (have not had an outbreak (herpes and shingles). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit (have not had an outbreak (herpes and shingles) was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm on his injection site arm), PYREXIA (Fever of 101.4 Degrees Farenheight), CHILLS (Chills) and MYALGIA (Muscle aches) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (Np medical history reported.). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm on his injection site arm), PYREXIA (Fever of 101.4 Degrees Farenheight), CHILLS (Chills) and MYALGIA (Muscle aches). At the time of the report, VACCINATION SITE PAIN (Sore arm on his injection site arm), PYREXIA (Fever of 101.4 Degrees Farenheight), CHILLS (Chills) and MYALGIA (Muscle aches) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided.
Can't determine if I had the 2nd dose; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The patient know he/she had at least 1 shingrix vaccine in 2021 but could not determine if he/she had the second dose. The patient asked that it was safe to start over with the series now since it was possible he/she had both the vaccine. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Nausea, vomiting, dizzy, diaphoretic, fever, chills, abdominal pain,  diarrehea , hot burning in left arm,  redness left arm, severe headache  pain, shakey , felt like I was going to pass out.  sick 4 days missed one night of work . I felt severely ill  and in pain.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: red line going down arm-Medium, Additional Details: Pt reports dark red line going injection site down to bicep; no fever
an expired dose of menactra was inadvertently administered with no reported adverse event; Initial information received on 03-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old male patient to whom an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Jul-2023, the patient received 0.5 mL expired dose 1 of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (batch number: U7190AA; Expiry date: 16-Jan-2023) via intramuscular route in the left arm for immunization, inadvertently with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event an expired dose of menactra was inadvertently administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About 2 weeks after getting the second booster shot, I started having dermatitis issues. I have seen a dermatologist and they believe it?s contact dermatitis. I think it can also be sebhoreic dermatitis. I have never in my life been allergic to anything or had eczema or dermatitis issues until after I received the moderna vaccine. I dealt with it continuously for 7 months and it still shows up occasionally 11 months after receiving the vaccine. I have heard many friends and colleagues breaking out in hives after getting the booster and their doctors/medical professionals are acknowledging they are seeing more and more patients with  hives and dermatitis issues.  I know these events are being reported please acknowledge that there are side effects to the vaccine that may occur. The vaccine is effective there?s no denying it?s saving lives but it?s your responsibility to acknowledge the scientific facts and do these studies if there are adverse effects to be honest with the public. Thank you
12 days after receiving Dtap, MMR, Hib, Varivax and Prevnar. Child developed (5) red spots on face, child was tired and felt warm to touch. Temp not taken. Rash spread (1) lesion on stomach, 6 on back of butt, on wrist band and a few above penis. No blisters, no scabs. 8/15 rash is improved and only found above penis.
Enlarged lymph nodes in both armpits to more than twice their normal size, armpits became convex. Lots of skin shedding on my hands, almost like Kawasaki disease. My hands are both peeling, starting at the nail bed, toward my palms. This has only increased since the day if vaccination.
Mother Reports child had a fever 100.4 temp., 130 pulse in the ER.  She was very weak, delusional, pain in arms & legs, HA, breathing heavily, O2 sat down, crying, arms & legs jerking, couldn't see nurse & Mom very well in front of her - everybody was blurry.  After pain med given in IV, 20 to 35 minutes patient was back to her normal self.  Mom reported this 8/17/2015 & stated that her daughter was fine that day.
Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 40-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 1, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 2, manufacturer unknown), for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  Additional information: The report was assessed as non-serious. The events did not result into death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
A report was received from a health care professional on 12/23/03 concerning a female vaccinee in her forties who experienced a circular rash and swelling at the site of administration approximately 12 to 24 hours after receiving Fluvirin on 12/8/03. Approximately 12 to 24 hours after receiving Fluvirin on 12/8/036 the vaccinee experienced a red, raised circular rash with soreness or tenderness and slight swelling at the site of administration. The vaccinee was treated with 1% hydrocortisone topically and recovered 2-3 days later. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site mass (arm is lumpy under the injection site), vaccination site warmth (arm is hot under the injection site), vaccination site erythema (arm is very red under the injection site), vaccination site swelling (arm is swollen under the injection site) and myalgia (muscle aches) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# C48AAA for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 10, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 11, 2021, patient experienced vaccination site mass (arm is lumpy under the injection site), vaccination site warmth (arm is hot under the injection site), vaccination site erythema (arm is very red under the injection site), vaccination site swelling (arm is swollen under the injection site), myalgia (muscle aches) and bad headache. At the time of the report, vaccination site mass (arm is lumpy under the injection site), vaccination site warmth (arm is hot under the injection site), vaccination site erythema (arm is very red under the injection site), vaccination site swelling (arm is swollen under the injection site), myalgia (muscle aches) and bad headache outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-040834 (patient link).
Pfizer-BioNTech COVID-19 Vaccine EUA Severe pain from area of injection to neck - inability to move and difficulty sleeping as a result. Started to improve after 12 hours or so. but still in pain. Now able to move.
I had  a sore arm immediately and then headache after an hour or so (I don't get headaches normally). this lasted for 3 days. Then i was ok for 2 days then my arm started to hurt and i got a runny nose and a mild headache and fatigue. My nose ran so much i did not work the next day. I received a negative covid PCR test. then 1 day later my left arm started to itch, turn red and swell. It has continued through today (the swelling is about 4 inches by 3 inches, over my left deltoid). i just took Benadryl. i am now on day 9 post vaccination.
Expired 2nd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment information was provided.
terrible pain in the shoulder and arm, difficulty with arm movement, inability to raise arm to the left, needed a small pillow to support shoulder to go to sleep that night
Mild hives on arms immediately after vaccination. Given BENADRYL, waited 30 min in office - hives starting to go away. Discharged to home. Advised s/s to look for further rxns.
SOB x 2 weeks, aching muscles, especially arms, painful breathing, elevated skin around injection, neck irritation, starting in mid-November. Dr did an EKG test which showed negative.
some difficulty swallowing; neck stiffness; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Patient medical history included high blood pressure, diabetes mellitus and swollen lymph nodes.Concomitant medications were not reported. On an unspecified date, patient stated he had some neck stiffness and some difficulty swallowing. He said he knew that these might be due to swollen lymph nodes but it was only on the left side and he got injected on the right side. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm was sore and red below injection site to elbow, warm to touch. Actual injection site was without redness or discomfort. Patient stated arm was already feeling better than it did the day before.
This spontaneous report was received from a licensed practical nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX (lot # M033214 expiration date: 13-JUL-2018 and lot # M009769 expiration date: 25-FEB-2018). The vaccines were exposed to 32 to 35 Fahrenheit degree for 2 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004034: US-009507513-1704USA004040: US-009507513-1704USA004042:
It felt like I had a flu coming on. I tested that evening, and it was positive. I called the doctor the next day. I had a prescription for PAXLOVID already due to precautions due to me traveling. I started taking it within a day of feeling symptoms. After taking it my symptoms were extremely mild. It was probably a week to ten days before I tested negative. I was using an albuterol and steroidal inhaler. I had little to no asthmatic symptoms. I was well for a couple of days and then I had a rebound. That was worse than the original COVID-19 symptoms. That was harder to get over. The rebound was a little longer than the initial symptoms.
Covid bivalent vaccine Hives , (weals and red blotches) on face, arms , front and back torso and legs. Itching.
Expired doses administered; Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not experienced any adverse effect.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Product start date, Expiry date and Event start date were updated. On 18-Nov-2021: Non significant follow up On 18-Nov-2021: follow up received contains event onset date and date of administration updated On 19-Nov-2021: Follow-up received on 19-Nov-21contains no new information.
Sudden unexplained infant death of 8MAR92; mom found pt w/o heart beat or resp;
Patient noticed pain on injection site 1 week later.  Patient found blister 4 cm from the injection site on the 7th day of injection.
Patient had a miscarriage in February.  Then in July '22 had pelvic pain.  Work up discovered mucinous adenocarcinoma
Experienced low grade fever at bedtime (100.2 - my regular temperature is 97.4) and had chills throughout the entire night and into the morning   The chills stopped around 12:00/1:00 PM on 03/27/2021 Temperature went down to 98 at 3:00PM after taking an Ibuprofen
The next day I had the shakes, like being cold, temperature, hot flashes, chills, diarrhea, and my whole body was aching and my lower back was in severe pain.  This lasted about 48 hours and I did't know about these side effects until after the fact.
: Spoke w/ pt. who stated she recd her 1st covid vaccine 2.5 wks ago, Pharmacy, Moderna.  At that time, she noted lethargy as her only SE, and mild redness at vaccination site. Now, however, there is a "4inch x 2 inch circle" around her left deltoid, and it is "blotchy inside the ring". She denies chills, fever, arthralgias, SOB, palpitations, urticaria. When she contacted pharmacy's she was advised to call her PCP.
she had loose bowels that began on 8/9 and resolved by 8/11. Later on in the conversation when giving isolation guidelines stated she started isolating beginning 8/3 as she was experiencing fatigue and tiredness.stated she was hospitalized on 8/11 and was discharged on 8/14. patient was admitted to Hospital because of her COVID symptoms. stated she was given a blood thinner several times while she was in the hospital
Really sick for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick for 3-4 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Really sick for 3-4 days). At the time of the report, ILLNESS (Really sick for 3-4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Additional information included outcome of the event
Swelling, both hands swollen and burning as if on fire . Nauseous and throwing up. Muscles and joint pain.
This is a spontaneous report received from contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (002591). A 70-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient felt abnormal/patient felt icky after the COVID-19 vaccine, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Ct. experienced flushing of face ,neck & chest and feeling warmth. Had a "tightness" in the chest. Tightness eased in about 10 minutes. 1035 BP-144/88 Pulse- 66. No visible diaphoresis. No visible hives or rash. 1045- BP-132/86. 1103-BP 138/80. Client reported no tightness in the chest and stated he felt he could go home with wife driving.
Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
right arm sore with difficulty lifting the arm without pain, stomach spasms, throat feels like closing off, coughing  Narrative: Patient received vaccine on 01/26/2021. Was assessed per the protocol and showed no signs of being unwell and was healthy looking. Vaccine was administered IM to RT arm. Patient then was monitored for 15 mins by staff over seeing monitor in clinic that day. After 15 mins time, patient was released. Pt call the call center the next day 01/27/2021 with a complaint of stomach spasms, sore arm that is difficult to lift with out pain being present, feeling like his throat is going to close off and starts to cough.
My mother reported having extreme fatigue immediately after vaccination administered and for two days. After a few days of improvement and feeling normal she woke up several days afterward and was unable to walk. After 6 days in the hospital with increasing weakness she was diagnosed with Guillain Barre Syndrome.