chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nervous; Trembling of fingers; Twitching of left arm; Right hand numb; Congestion in chest; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb) and CHEST DISCOMFORT (Congestion in chest) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb), CHEST DISCOMFORT (Congestion in chest) and HEADACHE (Slight Headache). At the time of the report, NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb), CHEST DISCOMFORT (Congestion in chest) and HEADACHE (Slight Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included some cough formula. No treatment information was provided.
Day following injection, he developed a painful pustule rash on the opposite arm. He assumed it was due to the injection day prior. He watched it. It continued to spread for 1 week until a follow-up determined he developed initial shingles outbreak.
This is a spontaneous report from a contactable nurse via a Pfizer sales Representative. This nurse reported similar events for three patients. This is the first of three reports. An elderly female patient received PREVNAR 13 (lot R33240, exp.date Mar2018, NDC number: 0005197101) at single dose on 01Feb2017 for immunization. On unknown date the patient experienced symptoms of redness at injection site, itching to the site, and heat to the site 1-2 days post injection, swelling and cellulitis. The patient received antibiotics for the cellulitis. The outcome of the events was unknown. Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-2017063634 same reporter/drug, similar events/patient; US-PFIZER INC-2017063635 same reporter/drug, similar events/patient.
No adverse event - 16-year old patient administered Moderna instead of Pfizer at this facility because pt received first Moderna vaccine at other clinic.
Presented to ED with complaint of tiredness and bilateral knee pain and left elbow pain pain that have been going on for the last couple days; tested COVID-19+ 2 days prior; asymptomatic.
Body aches; chills ( 1st & 2nd dose); menstrual period for 2 1/2 months straight; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (menstrual period for 2 1/2 months straight), MYALGIA (Body aches) and CHILLS (chills ( 1st & 2nd dose)) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced MENSTRUATION IRREGULAR (menstrual period for 2 1/2 months straight). On an unknown date, the patient experienced MYALGIA (Body aches) and CHILLS (chills ( 1st & 2nd dose)). At the time of the report, MENSTRUATION IRREGULAR (menstrual period for 2 1/2 months straight), MYALGIA (Body aches) and CHILLS (chills ( 1st & 2nd dose)) 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 concomitant product information was provided.  Treatment information was not provided.   This case was linked to MOD-2021-262867 (Patient Link).
This was reported by a healthcare professional via a inside sales representative and described the occurrence of black spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On an unspecified date the subject received unspecified dose of FLULAVAL at 0.5ml. At an unspecified time after vaccination with FLULAVAL, the subject developed a black spot about the size of a half dollar at the injection site. This was also considered to be a product complaint as the reporter expressed concern with the quality of the FLULAVAL administered. At the time of reporting the outcome of the black spot was unspecified. This was second call regarding this sort of adverse event from this inside sales representative that spoke with this facility. Previous events were filed with a QA report number of UV20080143. The facility called this inside sales representative stating that she had not been contacted regarding the first QA. She decided to use the product on another subject and they contacted her stating they had a half dollar size black spot at the injection site. The facility was concerned with the quality of the FLULAVAL. Linked cases include: A0752107A, A0752229A, A0752230A, A0752231A, A0752232A and A0752233A. Follow- up information received on 07 November 2008, via healthcare professional who reported the 54-year-old male subject experienced an additional adverse reaction was reported, details not provided. The events occurred on 22 October 2008 and resolved on 26 October 2008. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
pt recv vax 4AUG95 & on 28JUN96 pt exp chickenpox w/vesicular lesions in various stages, approx 40-50 lesions on trunk, arms, legs, & posterior of neck, pruritus;no further details were provided;
posterior cervical lymphadenopathy (1 swollen lymph node on the left side of the neck), measuring about 1 inch in diameter, was noticed 4 days after vaccination. no pain or redness at the site. no fever or other symptoms. mostly resolved in 2 days but continues to remain slightly enlarged after 9 days ( about 1cm diameter).
Attendee vocalized feeling lightheaded, self resolved with lying down for 15 minutes. No further needs
Information has been received from a pharmacist regarding to a patient of unknown age and gender. On 17-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot # 672932/0599AE, expiration date 22-JUN-2013). No other co-suspects were reported. No concomitant medications were reported. On 17-AUG-2012, after received ZOSTAVAX, the patient had redness and a raised bump around the injection site after received ZOSTAVAX. The patient did not receive treatment for the adverse event. The patient call to pharmacy for medical attention. The patient did not recover from the adverse events. This is one of several reports from the same source. Additional information has been requested.
Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac and had known allergies to computed tomography scan dye. 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 vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN), multivitamin (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (reported as Generic ZYRTEC); all medications from an unknown date and unknown if ongoing for unknown indications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy (Known allergies: Aspirin). On 22Apr2021 the patient experienced diarrhea. The patient reported that she never had diarrhea before but it became a daily occurrence since she had the vaccine. Therapeutic measures were not taken as a result of the event. 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.  The clinical outcome of the event diarrhea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
About two weeks after my second booster (4th shot), I suddenly started getting itchy patches on my skin that were like hives, but would go away after 15-20 minutes and then pop up another place on my body. When I scratched, there would be red welts that looked like scratch marks on my skin. It's still happening. I've never had allergies of this kind before. It goes away or diminishes if I take allergy medicine (Zyrtec).
Mom states pt arm was OK the morning p/vax but 2PM there was some redness & swelling-t99; seen by MD who states there was 1-2mm swelling w/2 square inches-rash around site of inject;
Had the expected fever within 24hrs which okay.  But 5 days later out of the blue I felt shaky, disoriented, sweats, fatigued hardly had the energy to stand or even speak, I was fearing I was having some kind of heart attack or stroke.  Something in my body was telling me something was very wrong, I have never had a feeling like this before in my life it was pretty scary.  I went to a place to be alone and sit since I could hardly stand, I sat for an hour and started to feel some relief.  It took almost 4 hours until some sense of normal was back.  I came home and went to sleep for the event tired me out immensely.  Since that days event and still ongoing I have been having random dizzy spells, I have days with absolutely not enough energy to walk out of bed and have called out of work because of it.  I get the feeling I am unplugged and then plugged back in as far as energy goes almost every day.  I have worse and better days with that.  About 2 to 3 times a week I experience  sudden pains and tingling that can go anywhere on my body but seems to focus more on all my extremities and back.  Feels like fire/pins/needles and it stays with me for a few hours to an entire day the pain ranges from a 5 to an 8.  My legs feel stiff every day now and at times sore yet I have done nothing exertive to cause that.  With the stiffness I have trouble getting my shoes and socks on, and getting up from sitting.  All these symptoms I didnt have until I took the shot.
Patient presented about 5 minutes post vaccination with dizziness and nausea. Patient maintained consciousness and did vomit slightly. After about 15 minutes the patient did feel better and left the pharmacy.
PATIENT REPORTED EXTREME PAIN IN JOINTS AND EXTREME HEADACHE THAT BEGAN HOURS AFTER THE SHOT AND LASTED ABOUT 24 HOURS
Numbness; Swollen arm; Body aches; Weakness of legs; Headaches; Sore arm; Tingling/Pins and needles throughout entire body; Fatigue; Chills; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 05Oct2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included lurasidone hydrochloride (LATUDA), melatonin (MANUFACTURER UNKNOWN) and trazodone hydrochloride (DEPRAX), all for unspecified indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 14Sep2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 22:00, the patient experienced headaches, sore arm, swollen arm, tingling and numbness, pins and needles throughout entire body, weakness of legs, body aches, fatigue, chills and fever. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit 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 events. The clinical outcome of the events headaches, sore arm, swollen arm, tingling and numbness, pins and needles throughout entire body, weakness of legs, body aches, fatigue, chills and fever were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Redness and swelling and hardness and pain to injection site a week later with rash and muscle pain
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a pharmacy administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Developed a severe case of shingles on my right side a day or two after receiving the second Pfizer exam. The pain, etc., has lasted for over a month although things have subsided significantly over the past week. I am a strong advocate for vaccinations and understand this may be a coincidence, but the timing does seem a bit suspicious and that's why I am reporting it.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 11:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 11:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.52 No concomitant medications were reported. On 03-Mar-2021 at 09:00 A.M., the temperature recorded was 51 degree Fahrenheit, at 10:00 Am the temperature recorded was 34 degree Fahrenheit and at 01:00 P.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. Product moved to clinic on 03-Mar-2021.  Vial was stored on cooler 1, on 03-Mar-2021, Excursion duration At 9 AM: 55, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM : 36, 3 PM: 36 and 4 PM: 36.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.
Pt arrived to COVID vaccine clinic Ambulatory with guiding cane (pt hx blindness). Pt received 2nd dose of pfizer and waited for 15 min post injection. While waiting for transportation pt states he felt sleepy as if he needed to lay down. Pt was escorted back to vaccine monitoring area and was assessed by RN. VS: 166/92, 174/101, 172/98, 171/94,  182/93. EMS was called to site. Pt wife was called for notification and to collect any recent changes in health. Pt status was drowsy and arousable, pt frequently would close his eyes not respond unless sternal rub was performed. Given his behavior and cardiac medical history pt was taken to  ER once EMS arrived.
This spontaneous report as received from a healthcare worker/medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, frequency, lot#, expiry date and indication were not reported), which was stored improperly for a period of 25 days. No adverse effect was reported. This report is one of three linked reports from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning an 18 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient reported multiple patients received a half a dose of FLUMIST QUADRIVALENT which started on 28-OCT-2014. The outcome of the event of multiple patients received a half dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Approximately 5-10 minutes after receiving 1st dose of COVID-19 Vaccine by PFIZER, while seated patient fainted. 911 was called and did respond. Pt was fully recovered before EMS arrived. Pt was evaluated and released by EMS, and was NOT Transported. Pt left on own accord.
Tried to do some shopping in the store after my 1st vax and really wasn't feeling well.  Tightness in chest, slight headache.  Several hours later I decided it might have something to do with my blood pressure.  Historically, my blood pressure has ALWAYS been extremely LOW. We have a machine at home for my husband.  My initial 2 checks came in with the top number at 188 and 166.  Later, it swung down to 140 and continued to vacillate from super high to high normal over the next 3-4 weeks.  After sending my BP records to my doctor she decided I needed to be put on BP meds to prevent a stroke.  This med did reduce my super high BP numbers, but my BP is still higher than the normal range and occasionally swings so low that I faint.  In August, I was taken off this med because of the swings AND the fact that the med started triggering my PVC condition.  Still working on sorting this out.
Patient was given a expired dose, Pfizer was called and info given to revaccinate the following day in the opposite arm.
I have had intense pain in my arm since the first of May, Went to my doctor and was given a shot of toradol and a shot of prednisone and oral prednisone, I am still having pain in my whole arm as well as weakness ,tingling ,I am taking over the counter painters and it helps some but the pain is constant and intense in the mornings.
This spontaneous report as received on 20-APR-2017 from a registered nurse which refers to one patient (age and gender unknown) who received an unspecified dose in VARIVAX (Lot number M040137, Expiration date 28-SEP-2018) immunization series that was improperly stored. The patient's pertinent medical history, current conditions and concomitant medications were not reported. The excursion details reported: The vaccine, VARIVAX (Lot number M040137, Expiration date 28-SEP-2018) was exposed to the Temperature (reported in Fahrenheit (F)) between 6F-14F for the time frame of 18.5 hours plus between 15F-46F for the time frame of 49.15 hours plus 47.8F (between 47F to 77F) for the time frame of 26.25 hours. There were no previous temperature excursions. The call was because of a data logger. No adverse effects reported. No additional information was provided. Additional information has been requested. This is one of two reports from the same reporter.
p/vax noticed sl swelling of the rt eye w/some redness, swelling has gotten worse;referred to MD;recovered;not seen by MD;
After 15 minutes the client had a non raised blotchy red rash on his upper chest and legs at the injection sites and reddened cheeks. The client did not appear to be itching the rash. The clients mother states that he gets red when he gets upset. The mother states the client is 25lbs and has no allergies. Per standing orders .3ml of benadryl was administered IM. After 20 mins the client was starting to calm down and the rash appeared to be getting lighter.
Dx:Cellulitis Left upper Arm Rx; Bactrim DS 800-160  tablet Q 12 hours X 10 days
Multiple Oral lesions that are lasting for over a month(like large canker sores the size of a pencil eraser and the size of a nickel)
I had tinnitus and sudden hearing loss in October 2019.  After taking high doses of valacyclovir, I regained some hearing.  About a week after my second Moderna shot, my Tinnitus became very severe and noticed that hearing was totally gone in left ear.