chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (medical assistant) reporting for herself. A 44-year-old Hispanic female patient was exposed to PREVNAR 13 (lot number: S58704, expiration date: Oct2019), when she was capping a syringe, and the needle broke off above the hub and scraped her right thumb. This occurred on 27Oct2017, when she was putting the needle on. The patient further described the event as; she was holding the syringe with her left hand and was holding the needle with her right hand. When she was putting the needle onto the syringe, it broke off, and the syringe scraped her right thumb because the needle stayed in her hand. She did have some bleeding and covered it with a band aid. The patient had no relevant medical history, concomitant medications or relevant investigations. The patient recovered from the events on the same day of 27Oct2017.
Day of second dose mouth started feeling funny. Woke up the next morning with blisters on her tongue. She reports extremely bad headache, body aches, extreme fatigue.   Overall feeling a bit better but tongue sores are still very painful. Notes headache and body aches are more mild.
Patient reported large portion of upper right arm became red and swollen then a week or so later her arm began to peel over her upper arm. It looked like she had a sun burn that had peeled.
Pt has a medium size rash at the injection site left arm. It's sore and hot. It is also lightly itchy. It seemed to get worse a day after the vaccine give. No treatment taken so far.
painful swelling in the armpit of left arm.; painful swelling in the armpit of left arm.; muscle pain; slight fever; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 16:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included severe obesity. The patient previously took sulfates and experienced allergy to it. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN), fish oil (MANUFACTURER UNKNOWN) and multivitamins for an unknown indication from an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 18:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 03:00, about 24 hours after the vaccination, the patient experienced muscle pain and slight fever. On 08Apr2021, in the morning at 04:00, 36 hours after the vaccination, the patient had painful swelling in the armpit of left arm and it was visibly swollen compared to the right armpit. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events muscle pain, slight fever and painful swelling in the armpit of left arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 16th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown. The reporter considered the injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: Concomitant therapies or other specific dosing details were unknown. The patient experienced red and itchy area at the injection site about 2 inch by 1 inch in diameter next day after vaccination. The current status of the symptom described as an injection site reaction was unknown. The reporter planned to see the patient at an office visit later today to examine the area. The reporter was transferred to the GlaxoSmithKline medical information team regarding her inquiry of whether or not symptom was typical of injection site reactions reported already within the PI and whether or not this patient should get the 2nd dose in the SHINGRIX series.
soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (soreness at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ARTHRALGIA (soreness at the injection site). At the time of the report, ARTHRALGIA (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants or treatment medications were reported.
Horrible reaction to 2nd shot. Sore arm, felt hot at injection site, small bump where injection was done, arm itched like crazy: approximately 2 weeks later symptoms appeared again; then again 2 weeks later same symptoms
Patient was given PROQUAD subcutaneous injection to right thigh as well as varicella vaccine. No adverse reactions occurred, follow up phone call made to family within 1 hour, no symptoms reported. Will follow up with patient within 24-48 hours.
a lot of pain in her neck to the point she can't turn her head; sharp pain in her left ear; pain when moving her head up and down; she can't turn her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "a lot of pain in her neck to the point she can't turn her head"; EAR PAIN (non-serious), outcome "unknown", described as "sharp pain in her left ear"; PAIN (non-serious), outcome "unknown", described as "pain when moving her head up and down"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "she can't turn her head".  Additional information: Patient reported that she had a lot of pain in her neck to the point she can't turn her head, sharp pain in her left ear, and pain when moving her head up and down It was very painful to the point of wincing and she could not drive. She saw on the internet some uncommon side effects of the vaccine were swelling of glands on the side of the head that the vaccine was received on. She had other, more expected types of reactions in the past.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient was given Pfizer orange cap 5yr to < 12yr at age 12yr and 6 months intramuscularly in the left deltoid at 0.2 mL Lot: FK5618  Exp: 05/31/2022 Primary Dose. Patient should have recieved Pfizer grey cap for age 12yr and older Intramuscularly at 0.3 mL. I have contacted the Manufacturer and the CDC and both state that a repeat dose is NOT to be given and that in 21 days he should revieve a secondary dose As the Pfizer covid-19 Vaccine 12yr and older. Patient and Parent have been contacted and notified. Remaining vials of Pfizer orange caps have been labeled as ages 5-11.
Patient presented to the doctor's office after developing hives two days after receiving his second vaccination. Per PA-C notes on 2/16/21: Patient notes that on 2/14/2021 he received the second COVID-19 vaccine in his right arm.  He notes he had the Pfizer vaccine.  Denies any reaction with the first vaccination however 2 days later he developed body wide hives starting on his back initially and spreading diffusely across his entire body.  He also endorsed some mild fatigue but otherwise had no symptoms from a second vaccination.  Denies any fever or chills.  States he has hives spreading out to his forehead and his nose.  He has been taking Benadryl and using hydrocortisone cream.  States hydrocortisone cream does not help.  Benadryl seems to help some but states he has been struggling to sleep due to the itching.  He does note some itching between the webs of one of his hands as well which is new as of today.  Denies recent travel or staying in a hotel/building other than his house.  No changes in laundry detergents, body washes, lotions, or soaps.  Notes he otherwise feels well.
Sore arm at site of injection.  Tired every day for a week.  Eight days later large red welt developed on arm at shot site.
Pt reported sudden onset of neuropathy in left fingers and arm approximately 15 minutes after administration of vaccine. Patient had identical reaction in 2017 from Influenza vaccine and was informed of risk this year. She willingly and knowingly agreed to get vaccinated for flu shot this year. Unfortunately, the patient developed an identical neuropathic reaction from vaccine this year as reported last year.
Within hours I am experiencing ringing in my ears.  Doubt I will be able to sleep tonight due to this.
Pt recvd 2 doses of Engerix-B & immed following both doses had redness, swelling, heat @ inject site, pain & lump;
She got sick after having COVID vaccine and after each booster; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She got sick after having COVID vaccine and after each booster) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis.    The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Psoriasis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On 08-Apr-2022, the patient experienced ILLNESS (She got sick after having COVID vaccine and after each booster). At the time of the report, ILLNESS (She got sick after having COVID vaccine and after each booster) outcome was unknown.            Concomitant drugs were not reported.  The patient had received booster dose on unknown date.   The patient was sick on 08-Apr-2022, due to medication for a kidney condition that causes stones.  No treatment information mentioned.  She had outbreaks during her last Skyrizi treatment was 28-Nov-2022. Reporters causality of event of Sick with Skyrizi was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621668 (Patient Link).
Nausea; Vomiting; fever; chills; fatigue; malaise; arthralgias; arm soreness; Dizziness; Headache; Tongue edema.
outside the recommended 12 hour vial puncture range; vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    Concurrent medical conditions included Drug allergy (Flonase), Food allergy, Drug allergy (hydrocholrothiazide) and Drug allergy (phenylephrine).   On 19-Nov-2021 at 7:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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. and INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) (Intramuscular) at an unspecified dose. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (vial of the Moderna vaccine opened yesterday evening and then it was given today. It was left in refrigerator overnight) to be not related.    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Included case classification, patient demographics, medical history (Allergy) added, suspect drug start date, dose numbers and start time for booster dose added, Co-suspect drug information and events start dates were added.
irregular heartbeat (daily, several times per day, heart flutter) shortness of breath, fatigue
Patient developed blue discoloration in her hands and feet 2 hour after receiving her Moderna 0.25mL booster. Approximately 24 hours after receiving she developed fever, nausea and vomiting.  All adverse reactions completely resolved 48-72 hours after receiving her dose.
Redness,  slight swelling, achy muscle,  This occured immediately after vaccine, went away on its own. Reoccurred 10 days later with itching off and on
Patient developed Type 1 diabetes after his Covid-19 vaccination. He had no family history or symptoms prior to the vaccine.
High fever and body aches over 48 hours. Oscillating tylenol and ibuprofen every 4 hours, lots of fluids, and ice packs on major arteries along with tepid baths. Fainted walking up stairs. Fever up to 104 at 48 hour mark. Still ongoing currently
client was sitting in observation area,  and found onto floor, began to shake for about 3 seconds. client  was assessed BP within normal range 122/85, O2stat 99, HR 82, Resp. 18. client stated he did not eat or drink this morning and has a phobia of needles. client was provided with fluids and food.
sore arm; A spontaneous report was received from a consumer concerning 70 years old, female patient who experienced Sore arm.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 012620A  on 17-Jan-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced Sore arm since 18-Jan-2021. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the reported event Sore arm was not reported.   Company Comment: The reported event, Sore arm was considered possible to mRNA-1273.
The LEFT arm hurt and was a little hot...(The arm that the PneumoVax23 was given in)  at around 24 hours it was noticeably very red and hot to the touch,  I drew a line around it with a pen and took pictures.  it extended from my deltoid to my biceps .  by 36 hours it was more red and swollen.  I iced it and took Advil.  When I woke up that next morning the swelling had gone down and it started to feel better so I did not seek medical attention for it.  I did not think it was an "emergency" that needed attention on a weekend night shift.
This spontaneous report was received from a nurse and refers to an unspecified amount of patients of unknown age and gender. No information about the patients pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # L011846 with expiration date 16-JUN-2017 and lot # L013429 with expiration date 21-JUL-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
experiencing some tiredness, fatigue; feeling achy, pain, in body throughout; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient received dose of Shingrix vaccine, after receiving the vaccine, the patient reported that she experienced some tiredness, fatigue, and feeling achy, pain, in body throughout.  The symptoms were resolved without intervention from health care professional. The patient disconnected the call, no other information was reported. The reporter did not consent to follow up.
At and around the injection site, my arm became red, swollen and very itchy.  This lasted for approx 24 hours. I received the flu vacc the day prior; not sure which one it was as that information was not provided to me.
Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (Could not walk). At the time of the report, GAIT DISTURBANCE (Could not walk) outcome was unknown.            No relevant concomitant medications were reported On 17-Feb-2021, the patient was fed up and could not walk. The patient's husband had to carry her to the bathroom. The patient shuffled and was not able to move the feet. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Bedbound; Sick; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bedbound), MALAISE (Sick), VOMITING (Vomiting) and PYREXIA (Fever) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Bedbound), MALAISE (Sick), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, BEDRIDDEN (Bedbound), MALAISE (Sick), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
on 03/22/2021 I had a red inflamed area on left Achilles tendon area, off work for two days, negative US for DVT I had twisted my knee on 03/29/2021, negative DVT MRI meniscus tear I got a blood clot behind my left knee on 04/04/2021  left calf started hurting on 04/01/2021, got intense on 04/04/2021 went to UC US was positive for DVT I have never had one, no health issues, was advised to report blood clot
The caller received the first dose of the Pfizer Covid vaccine on 20Apr2021. The second dose was on 11May2021, but on her vaccination card sticker says Jansen; Her blood pressure is low, not qualified low, but it runs like 96/69; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20Apr2021 (Batch/Lot Number: EW0153; Expiration Date: Jul2021, 42-years age at the time of vaccination) as single dose for covid-19 immunisation. Medical history included endometriosis from 1997 to ongoing. Patient has endometriosis and is suspected to have it right now. Has had it her whole life and had 4 surgeries, the first in 1997. The patient's concomitant medications were not reported. The patient experienced the caller received the first dose of the Pfizer covid vaccine on 20Apr2021. the second dose was on 11May2021, but on her vaccination card sticker says Jansen  and her blood pressure is low, not qualified low, but it runs like 96/69 on 2021. Patient had labs yesterday and everything was normal and Her blood pressure is low, not qualified low, but it runs like 96/69 in 2021. Reporter also stated that She just noticed today that she was given the Johnson & Johnson for the second dose. She called the pharmacy who told her they have no way of knowing if they messed up the sticker. She would like the second shot but now has the first shot of Johnson & Johnson. She has had zero symptoms. She did not have any symptoms with the first dose. Everyone she knows that had Pfizer had no symptoms. The sticker has Jansen 0.5ml listed in this spot.The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.