chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Small cut on hand from a broken vial; Adjuvant was in hand / the entire bottom of the bottle came out; Adjuvant was in hand / the entire bottom of the bottle came out; vial issue; Had a broken vial of SHINGRIX adjuvant/ PQC filed; This case was reported by a other health professional via call center representative and described the occurrence of laceration of hand in a adult male patient who received Herpes zoster (Shingrix) (batch number 2J5BF, expiry date 6th October 2023) and (batch number HY975, expiry date 6th October 2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced laceration of hand, occupational exposure while preparing product for administration, exposure via skin contact, product vial breakage and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of hand, occupational exposure while preparing product for administration, exposure via skin contact, product vial breakage and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of hand to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comment: The reporter was a customer who is a pharmacy technician. The reporter stated that they had a broken vial of Shingrix adjuvant. The reporter reported that it was not noticed that the vial was cracked, until a colleague was warming the adjuvant in his hand, and the entire bottom of the vial came off.  The colleague received a small cut on his hand from this vial. The reporter stated that after partial use of the pack during the preparation this defect was discovered and the product was not administered to the patient. The healthcare professional who was preparing or administering the vaccine was an experienced person. Due to the vial was discarded the pictures are not available and there was package, carton or blisters tray are not damaged. There was no any evidence of leakage of product in package or carton. The reporter reported that there was a hairline crack that went all around the bottom of the vial. The crack was observed on the bottom of the vial. The suspect vial was not available for return as it was discarded. Additional supportive information: The vial was cracked and warmed on the patient hand which led to, occupational exposure while preparing product for administration and exposure via skin contact
I had increased frequency and urgency for urination. I also had blood in the urine with discomfort. Yesterday I went to get the health center to get tested for a UTI and it was confirmed that it was a UTI. I was prescribed generic MACROBID to treat my symptoms. I began to take the medication yesterday and I think there has been some improvements in the symptoms. I am not sure whether I have completed recovered as I have just begun the antibiotics.
There was a knot in my arm that lasted for more than a week, but the biggest reaction is that on the 2nd day after vaccine administration, I developed SEVERE flu-like symptoms and extreme lethargy to the extent that I had to do a 'tele-doc' type of appointment to get instructions/relief from symptoms. My symptoms involved temperature of 102,  joints aching and movement hindered somewhat, and extreme headache, and accompanied by nausea.
Patient reported having headache, nausea and dizziness x 12 hr. after 1st dose of vaccine. Resolved without treatment.
This spontaneous report was received from a medical assistant regarding a currently 75 years old female patient. The patients' concurrent conditions, concomitant therapy, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # N025563,expiry date:08-APR-2019) (strength, dose, frequency and route of administration were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature involved was 72-degree Fahrenheit for time frame of 48 hours. There was no previous temperature excursion. No data logger involved. No product quality complaint involved. This is one of two reports derived from same source of information. Sender's Comments: US-009507513-1804USA002459.
Information has been received from a physician concerning a patient who on unspecified dates was vaccinated with first and second dose of VARIVAX (Merck) (dose, route and lot number not provided). The physician reported that the patient developed a stomachache 3 minutes after receiving the second dose of VARIVAX (Merck). The patient recovered from the event on an unspecified date. The patient sought medical attention at the office. Additional information has been requested.
when  withdrawing syringe from patient's  arm, a bit of vaccine trickled  down  arm....Perhaps 0.1 cc
Patient husband provided all information except email address He stated his wife has been at Hospital since the 09/01/21 for covid and is still having symptom but is doing much better
Vomiting, shakes/tremors, weakness, headache, numbness and extreme tiredness.
Patient reported severe malaise, upper arm/shoulder pain that continued from the time of injection and began resolving on 10/08/17 when patient come in to report symptoms. Patient also mentioned joint pain but did not describe further and stated that that syptom had been resolving.
Fever, Chill, Body Aches, injection site pain - Tylenol 1000mg every 8 hrs for 24hrs - symptoms lasted 24hrs
tingling in my lower spine the same day of the shot. Next day tingling traveled to chest (left side). The day after to the right side of my head by temple. Muscle tremors began on my mouth and chin afterward. Then muscle tremors on hands and feet. The muscles spasm were over a span of about 3 weeks. Then began severe and painful muscle cramps, in my legs, feet and hands. I am in menopause and I felt menstrual cycle cramps after not having a menstrual cycle in 3 years. My left knee gave out sporadically but I was able to maintain standing with my right leg.
Rash on Right upper arm - Rash does not look like an allergic rash but looks like a heat rash
Chest pressure sensation; also accompanied with slight burning sensation/chest sensation as internal; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EL1283; expiry date: 30Apr2021) via an unspecified route of administration on 22Jan2021 about 10:57 AM at left arm at a single dose for COVID-19 immunization. Patient History and other products were reported as no. The patient experienced chest pressure sensation on 22Jan2021 with outcome of resolving. The details was as follows: the patient got the vaccine today (on 22Jan2021) about 10:57AM. When getting the vaccine they made his go through stalls, it was multiple cars on each side, what stood out to him was, when his vehicle moved up, he was the driver in this case, and so the vaccination was on his left arm, when the gentlemen went to insert the needle, he expected it to be a green needle attached, but the color of the syringe was black with a black band. He noticed the car before had a green attachment for their needle and the syringe, it was Green and clear looking but his was black. He asks if the color of the needle is suppose to be a certain color. Caller was informed that he may need to contact the facility from where he received the vaccine for this clarification. He also adds that he was okay for the 15 minutes, but then he left feeling a little sensation in the chest that he did not have before, it was not superficial on the skin it was internal in his chest. He was naturally calling to see, what he could find out, are there multiple colors for the needles or were they standard, green or clear plastic. He also would like to know if Pfizer directs the administration of the product to be drawn up in front of the client. The chest sensation started about 1:30 or 2 o clock PM the same day, he described the chest sensation as internal, in the center of the chest, sort of like a pressure downward, also accompanied with slight burning sensation, something that was different that he had never usually felt. He also asks if there was a certain protocol or standard the folks administering the vaccine were suppose to follow. The outcome of event was reported as the chest sensation has dissipated a little in terms of intensity, but he felt as if it was trying to be dormant in that area.
In 2003 a requirement for me to deploy to a foreign country to work at a store, I was required by the DOD to get the entire series of anthrax vaccinations. I am hearing now from co-workers and friends who were on active duty at that time that the vaccine was in fact not good for me and could have some adverse and permanent effects or damage. I have been experiencing problems concentrating, insomnia, intermittent shaking of hands and arms, weight gain, body aches. I am now just finding out about this so I have had no testing done as of yet.
Stomach pain to the point of vomit, extreme nausea, lasting for over a week and a half, dizziness, swollen arm, itchy arm up to 10 days latter.
pt to ED c/o weakness, fatigue, dyspnea, unable to ambulate, hyperglycemia, diaphoretic, hypoxemic, cyanotic, tachycardia, hypotensive, COVID positive, sepsis, respiratory failure; treated with Levophed, Baricitinib, remdesivir, dexamethasone; pt experienced cardiac arrest; CPR performed but pt died in the ED
Tinnitus off and on in left ear; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 17Apr2021 at 12:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) 15 mg and levothyroxine (MANUFACTURER UNKNOWN) 150 mcg; both from an unknown date for an unspecified indication and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced tinnitus off and on in left ear. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus off and on in left ear was unknown at the time of this report.
Vaginal bleeding started 2 days after shot..  it has been almost two weeks and still bleeding.
Pt stated she had anaphylaxis (throat swelling and closure) at around 10pm.
9/20/2010 1230-100 receive injection by 6:00pm (L) arm sore - 900 took TYLENOL & BENADRYL for discomfort ? reaction went to bed 10:20AM could not raise arm - went back to clinic different person on said to contact you - was like arm was paralyzed; not able to use.
Muscle aches, soreness and joint pain on the injected arm were experienced for roughly 3 days. Took APAP otc to alleviate the pain and was recommended to move the arm around and stretch it to help with blood flow.  By the evening of the 3rd day the pain and discomfort did go away and was feeling much better. Followed up a week later and patient was doing okay with no complaints.
2 days after shot had headache, chills, naseau. dirrhea.next three days had rash all over body, itchy cough
Right upper arm large erythematous rash at the site of PCV 13 injection, no discharge, no bleeding.
High fever for 2 days -topped out at 104, muscle aches and pain, Chest pain and mild breathing issues, and extremely tired
Headache; Body Aches and Pains; Redness at the injection site; Edema at the injection site; A spontaneous report was received from a physician concerning herself, a 48-year old, female patient who received Moderna's COVID-19 vaccine and experienced redness and edema at the injection site, body aches and pains and headache.    The patient's medical history was not provided. The patient's concomitant drug included Diabetes medication for Diabetes.   On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient began to have redness and edema at the injection site. On 04 Jan 2021, the patient began to have body aches and pains. On 05 Jan 2021, she reports having a headache.    Treatment for the events included naproxen sodium.  Action taken with mRNA-1273 in response to the events was not reported.   The events, redness and edema at the injection site, body aches and pains and headache, were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Symptoms - Scratchy Throat, Muscle Aches, Chest Pain & Pressure, Fatigue, Congestion, Runny Nose, Headache, Shortness of Breath, Dry Cough, Sharp Pain in Left Rib  Friday 1/7/21, visited Urgent Care for a Covid 19 test.  PCR test results showed a positive result for Covid 19.
lhe patient was administered an improperly stored dose of Rotateq; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 24-MAR-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: 1660112, expiration date: 18-OCT-2020) (exact dose and route of administration were not provided).   The vaccine experienced temperature excursion above 47 degree Fahrenheit 52.1 F for 15 minutes Previous temperature excursion was detected above 47 degree Fahrenheit 55 F for 21 minutes. Digital data logger was involved.
Reaction occurred at drive thru vaccine event. Pt. reports face tingling and EMS was notified of allergic reaction. Vitals reviewed and WNL. EMS assumed care of the patient.
Rash; Rash; This spontaneous case was reported by a nurse and describes the occurrence of the first episode of RASH (Rash) and the second episode of RASH (Rash) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included APIXABAN (ELIQUIS), EZETIMIBE (ZETIA), FUROSEMIDE (LASIX [FUROSEMIDE]), METOPROLOL, AMLODIPINE, OLMESARTAN, ALPRAZOLAM (XANAX), DIGOXIN, MULTIVITAMIN [VITAMINS NOS], FISH OIL, VITAMIN E [VITAMIN E NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D3, DENOSUMAB (PROLIA) and PROBIOTICS NOS for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced the first episode of RASH (Rash). On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of RASH (Rash). At the time of the report, last episode of RASH (Rash) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include osteo bio flex three to four times weekly.  Treatment for the events include anti-itch gold bond cream.  The patient experienced Rash(red and itchy in nature ) from the shoulder to the elbow, which got spread to all over the body.
received just the adjuvant; received just the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   On 2nd November 2021, the patient received the 1st dose of Shingrix. On 2nd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant reported that, the patient received just the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter consented to follow up.
2 days after receiving the ZOSTAVAX injection, patient developed a pink, 5cm hard lump at the injection site. On the 3rd day, the area was soft and by the 4th day after injection, the site was normal.
Patient came into vaccination pod and was accompanied by a previous patient whom got her first dose earlier that morning. The guardian was vaccinated with a 12+ pfizer vaccine and requested the same for the patient she brought in.  The administrator for the day registered the patient into the clinic system before the PrepMod system and proceeded to vaccinate the 11 year old with a (0.3mL) dose rather than a (0.2mL) dose.  The pediatric patient showed no adverse symptoms and was called a few hours to check in on the patient and inform them of the mistake. The patient's guardian reported only muscle ache on the injected arm - nothing else. She was informed to please inform of the patient's age and required dose when returning for the second dose.
Left shoulder pain, pt. was given narcotics for the pain on 10-22-12. Dr. gave pt. a cortisone injection on 10-25-12.
Aggravated tremor in right hand (shaking); swollen fingers on both hands; both feet: tingling (not Gout symptons); feeling of spiders crawling in my legs; profuse sweating; hot flashes; nausea; light headed; dizzy; I could feel every single joint in my body - especially hips and fingers; tired and "worn out"; spent Friday PM and all day Sat. in bed.  Last evening (Sunday, 6/21/2020) felt a tightness in throat - but drank plenty of liquids.  General feeling of something not right!!! Monday, 6/22/2020 - right hand is still shaking (typing w/two hands). Standard redness and swelling of area where injection was given
she had localized pain on the injection site after receiving the 4 doses,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No information was provided regarding patients past Medical History, allergies or acute and chronic illnesses at the time of vaccination.  Concomitant products included CANNABIDIOL (CBD OIL), SIMVASTATIN and FAMOTIDINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,). At the time of the report, VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine Patient has not yet diagnosed or tested positive with covid   This case was linked to MOD-2022-554212, MOD-2022-554220, MOD-2022-554221 (Patient Link).
After approximately 20 minutes of having the vaccine I experienced bright red facial flushing . It diminished slowly over the next 24 hours .
PATIENT'S LEFT ARM BECAME SWOLLEN/RED/INFLAMED AROUND GENERAL SITE OF INJECTION ON 10/11/17. PATIENT WENT TO MD ON 10/13/17 AND WAS PRESCRIBED ANTIBIOTICS.
Patient is complaining of pain during the day and unable to lift her arm above her head.  It is numb in the morning after she sleeps on it.
Within first 3 to 5 minutes had symptoms. Within 10 minutes increased temperatures, (wave of heat in body) tightness in throat, heart pounding, weakness in legs. Went to fresh air, some sympyoms resolved then came in short spurts (throat). Had motion sickness, nausea, dizziness while in ambulance.  Could be from fumes from cars in parking garage, idling and lack of oxygen.
I received the first dose of the Pfizer vaccine at 9:15 AM on March 9, 2021.  I then returned to work. At about 4:30 PM on that same day, I started feeling dizzy. I felt like I was going to faint at work. Every time I would stand up, I would feel like I was going to pass out.  I had someone drive me home because I felt that I was too dizzy to drive. I arrived home at 6:00 PM and began to vomit profusely. I threw up all night and had the chills.  In the morning, I felt better but still had a dizzy feeling. The dizziness and vomiting completely  subsided by March 11,  2021.    On March  12, 2021, I noticed that I had floating black spots in my left eye accompanied by a painful migraine. I have never had eye floaters or migraines previous to this vaccine. My migraine lasted for 5 days straight and I had to be off work to go to the emergency  room because I started to loose vision in my left eye. They were unsure of the cause because I did not have any pre-existing health conditions.  The migraine finally subsided after the 7th day. I have had eye floaters every since I got the vaccine. I?ve been to an eye doctor and my primary and they all have told me that it could be from this vaccine because I have never had the problem until I received it.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid treatment from 21Nov2022 to 25Nov2022.; Sender's Comments: A contributory role of BNT162B2, BNT162B2 OMI BA.4-5 to event covid-19 cannot be excluded based on temporal association and available information.