chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional via a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 7 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 7 October 2008, and into the next day, the subject developed a generalized itchy rash. On 21 October 2008, the events of rash and itching were resolved. The healthcare professional considered these events unrelated to vaccination with FLUARIX. Similar events occurred in three additional subjects. Linked cases include: A0753760A, A0753769A and A0753770A. Follow-up information received on 07 November 2008 indicated that the events actually began on 08 October 2008. One day following administration of FLUARIX. The events resolved.
Hives after second shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives after second shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced URTICARIA (Hives after second shot). In March 2021, URTICARIA (Hives after second shot) had resolved.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-329316 (Patient Link).   Reporter did not allow further contact
patient was administered vaccine which had undergone several temperature excursions.; No Adverse Event; patient was administered vaccine which had undergone several temperature excursions.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No Adverse Event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if  the patient ever been diagnosed with/ tested positive for COVID-19.     On 23-Sep-2022 at 11:54 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions.).    Concomitant product use was not provided by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Vials were moved from freezer to refrigerator on 7SEP2022 It was reported that Refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation.  The vial size was reported as 5.5ml.  Treatment information was not provided.
Patient had fairly severe soreness on both left and right upper arm that persisted for 2 weeks.
Patient was shaky and passed out about 5 minutes after receiving vaccines. She came to and said she felt fine, but was encouraged to go to the hospital to get checked out.
Red rash at injection site.  Warm to the touch, hard, painful and itchy.  Slowly got worse from vaccine date and was the worse on day 10 before resolving.
Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.
tested for covid last Monday and the results came back negative; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 08Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Feb2021, the patient experienced tested for COVID (sars-cov-2 test) last Monday and the results came back negative. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Pt's mom reports redness, warmth covering entire R thigh next AM follow DTaP.
Patient was fully vaccinated with the Pfizer vaccine on 1/14/2021 and 02/03/2021 and has now tested positive for COVID-19 on 6/28/2021
9/9/22 Received call from mother at 3:41 am and she reports patient had a syncopal episode and is now laying on the floor after family had to remove him from the shower.  He is breathing and talking but can not described exactly what happened.  He reports he hit his head and legs feel tingly and he has nausea.      After calming family on speaker phone, I was able to obtain a more detailed history from mother and patient while patient was laying on the floor.  Mother reports after his well visit today, patient had a milk shake, then they returned home and had dinner.  He seemed fine and went to bed at a typical time, then awoke around 2am complaining of headache so mother gave him some motrin and water, No fever or other noted symptoms. Soon after he had one small emesis then went back to bed and then had another large emesis and which had gotten all over him so mother had him take a shower.  Mother reports while he was in the shower she heard a large thud and they found him on the floor of the shower.  His parents and brother lifted him out of the shower and on to the floor then called MD.     I asked patient if he remembers what happened and he recounted the events of before the shower and reports in the shower he remembered reaching down for the shampoo and then awoke on the floor, he does believe he bumped his head but does not know on what.  He states he is still a little nauseated and feeling a little tingly, no bleeding or visible bruising per mother.     I asked if he thought he could sit up, he was unsure, I asked family to assist him in sitting up to see if he could tolerate this.  Immediately upon them trying to help him sit up, he said he felt bad and like he was going to vomit again.  Started to feel faint again.     Based on this, I advised mother to call 911 for evaluation and transport to the hospital for evaluation as patient was not able to get up and as he is an adult size it would not be safe for them to try to carry patient to the car for transport.  Mother verbalized understanding of the plan and will hang up to call 911.   Seen In ER and subsequently discharged after evaluation dx with syncope.  CBC and CMP done in ER and notable for mild abnormals in cbc and Bilirubin.  He was discharged from the ER within a couple hours with recommendations for cintinued hydration and rest.  Patients symptoms completely resolved and he was well.    Follow up repeat labs are planned for 1 month from now with PCP.
febrile seizure w/in 8 hrs p/receiving 3rd DTP (in the form of tetramune);
Erythema (palm sized), chills, cold-like symptomes for 2 days
given expired Fluzone Quadrivalent / no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA262273.  This case involves a 7 years old female patient who was administered an expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot UT6375LA (Expiry date JUN-2019) via intramuscular route in the left thigh on 13-Sep-2019.  The patient's past medical history, vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At a time of reporting No adverse reactions reported.  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 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.  List of documents held by sender: none.
Shingles.  The day after the second dose of my Pfizer vaccine I felt numbness and tingling on the left side of my body.  Specifically on the left side of my left arm and down through the left pinky finger.  I also had the same sensation/numbness down the left side of my left leg and into my left pinky toe.  The sensation is intermittent and typically on the left side (the same side of the body as the injection).  Two weeks later I began to feel more tingling on the left side including up through my left jaw and on the left side of the top of my head.  The following day I realized I had two blisters under my left arm pit which made it clear I had shingles.  Today is 3 weeks since my second shot and I still continue to feel numbness and tingling.
Dizziness, Headache, Myalgia, sore throat, fatigue, swelling Narrative:  Other Relevant History:
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients received improperly stored doses of (Oka-Merck) PROQUAD lot # M006104 with expiration date 01-AUG-2017 and lot # L031600 with expiration date 18-FEB-2017 (dose and route of administration were not reported). The vaccines underwent a temperature excursion of 14.4 degrees Celsius for 30 minutes and 13.3 degrees Celsius for 1 hour. Data logger was used. It was provided that vaccines underwent previous excursion at 9.0 degrees Fahrenheit for 7 hours on an unspecified date. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
I have some mild tinnitus which I've had for 15 years since high school and rarely bothers me. Go months without noticing it.   A few hours after my first dose of Pfizer (left arm), I got a headache and some queasiness. The expected side effects. My ears started ringing louder and more pronounced, which I assumed was a side-effect of the headache and/or immune response to the vaccine. It's past two weeks now since dose 1 and my ears are still ringing much more loudly and noticeably than in the last 15 or so years. All other side effects have long ago subsided. It seems to be worse in left ear, the same side I got shot on. I imagine that's irrelevant, but mentioning it anyway here.   Distracting and distressing.  Am scheduled for a second dose on April 21 and now hesitant about getting it.
Caller reported temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-FEB-2020, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, for prophylaxis (lot # T017688 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 21-MAY-2022) (strength, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were -13.3° Celsius (C) for 4 hours and 15 minutes respectively.  A digital data logger was involved, and there was not previous temperature excursion.
2x8cm red induration, warm and itching developed next day. Vaccine was given on 3/20/06. Treatment: Benadryl, ice.
C/O small red raised bump to R wrist. Pre-existing red raised bump on R upper eyelid with swelling.
Patient states shot administered too high, bursa punctured, shoulder sore for more than a week, went to an orthopedist for steroid injection
Patient's left arm became swollen and painful after she received the shot on 01-03-2022. She says it's still swollen and painful on 02-10-2022 when she came into the pharmacy. She has already visited the doctor to report the adverse effects and will be continuing to follow up with her doctor to discuss future treatment.
On September 1st, I took her back to the doctor and he said she had a slight case of encephalitis.  On September 10th her temperature was 104 at the highest and has been ranging about 102-103 for the last 30 hours.  She is listeless and irritable. Follow up report states: One year old child received MMR and varicella vaccines; told by MD that child might get a fever 10 days later. PMH significant for atopic disease for which child received antihistamines; occasionally child "stumbled" when tired or when taking this med, even before MMR. Was brought to MD office at about 8-10 days after vaccines for rash; noted to be pulling head to side, walking a bit tilted; mother said child was "stumbling" all the time. Interacted fine, except wanted to be held. Always recognized family members, no seizures, no change in mental status. Told by doctor she had a "touch of encephalitis." No labs, went home. Day 10 developed a fever of 103-104, lasted 3 days. Mother looked at CDC website, called CDC, told "fever should not last that long' and brought child to CCMC. In ED there was told there was no such thing as "a touch of encephalitis" and that the child had rashes of bother varicella and measles. Had rash on palms and soles. No lab tests done. Sent home. Fever broke after about 4 days, and child returned completely to her ususal self. Currently completely well. Mother very pleased with how child is doing now.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird), JOINT SWELLING (knee swell up), SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 439905) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, CARVEDILOL and ENALAPRIL for Prophylaxis and Hypertension, ATORVASTATIN CALCIUM (LIPITOR) and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 13-Nov-2021, the patient experienced SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up). On an unknown date, the patient experienced JOINT SWELLING (knee swell up). At the time of the report, PAIN IN EXTREMITY (Arm was sore after booster shot), VACCINATION COMPLICATION (Felt yucky again, Something weird), JOINT SWELLING (knee swell up) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and SKIN DISCOLOURATION (It was just the right hand, Started turning black and blue, It was purple almost, It was purple almost, Hand turned purple) and PERIPHERAL SWELLING (on right side, the right hand started swelling up) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided by reporter.   This case was linked to MOD-2021-387092 (Patient Link).
4/1/21 - When data logger was downloaded to order vaccines on 3/31/21 it was noted for an alarm on 2/9/21 for excursion on 34.5 F for 20 minutes.  On 2/9/21 Frozen moderna was placed in the vaccine refrigerator to thaw. Called to report excursion and check on vaccine stability with each manufacturer.  Per GSK -  Case reference # 01019026; GSK vaccines "stable until expiration date"  and per Merck - Case reference # 01900380; Merck vaccines "may continue to use until expiration date"; Sanofi Pasteur - Case reference # 00544442; Sanofi Pasteur vaccines all except IPV/ Fluzone HD which this client did not receive these 2 vaccines.
Crawly skin, painful skin, blurry vision, dizzy, fell asleep until midnight, awoke with clothing hurting skin by touching it, cold chills, headache, nausea, took Advil with no result, took Bayer, still no result, slept until 10am, dizzy and tired on 9/22.
Pt received Pfizer dose #2 on 3/1/21 at 1607, c/o N/V, diarrhea, fever on 3/2/21 requiring pt to go to ED for evaluation.
chills, fever, bruising, swollen glands, body pain, fatigue, weakness, headache, general inflammation, depression, 7 days
Administration of second dose of Moderna, patient was only given 0.3ml  instead of recommended dose of 0.5ml
R upper arm red, swollen and painful to touch. Antibiotic tx started alogn with Tylenol/ Motrin use.
New onset Parkinsonian type tremmors, confusion.  Onset approximately 8 hrs post vaccination.
Body aches, nausea, chills, headache, joint stiffness, dry eyes, cramping of muscles
w/in 1 1/2hr of vax began devel mosquito bite size lines all over body, eventually all blended together;abd, face, ears, & thighs the worst;tx w/DPH in ER & cont for 24hr;
On 4/28/09 Mom called on her son who had shots on 4/27/09.  His left leg is sore, red and hot today.  I told mom to put ice on his leg and have him use his leg alot today.  I asked her to let us know if it doesn't get any better.  He got DTAP and IPV in his left leg.  On 4/30/09 I called mom to see how pt was doing.  She stated they took him to the E.R.   On 4/28/09 that night because the swelling was getting worse it  had spread to his knee.  The E.R. Dr. told her it might be an allergic reaction or an infection.  He was given Benadryl at the hosp.  and a RX for an antibiotic.  Mom never filled the RX for the antibiotic because the Benadryl is helping alot.  The swelling is down and he is feeling better.
Initial unsolicited case received from a physician's assistant on 30 March 2015. A 57-year-old male patient, with a history of HIV and Hepatitis C, received a right arm injection of MENOMUNE (lot number UH537AA) and a left arm injection of PREVNAR (lot number J67646, Pfizer) on 30 January 2015. Multiple allergies were also reported, including latex, acetaminophen, ciprofloxacin, other unspecified antibiotics, meperidine derivatives, and lactose. An unspecified amount of time following vaccination, the patient reported right arm pain to the armpit, right scapula pain, and right hand weakness. The patient, who was himself a neurologist, was seen by a neurologist on 06 March 2015 and diagnosed with brachial plexitis from vaccination. Treatments and laboratory tests were not reported. The symptoms were reported as improving, although some pain in the right scapula and arm, in addition to weakness, still continued at the time of the report. Documents held by sender: None.
Deltoid muscle is swollen with erythema 4 1/2" long x 4" wide. Very warm to touch and painful. Severe redness from shoulder to elbow. Skin is tight.
No additional adverse effects reported; an adult patient was administered a pediatric dose; This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 12-MAY-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) strength reported as 25/0.5 (units not provided), lot #S032056, expiration date 09-NOV-2020 (exact dose, site and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse effect was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Myalgia, Arthralgia,  Fever & Nausea Vomiting Narrative: My second covid shot was taken after 21 days on 7th Jan, 2021. Very  next day I got the same reaction. I felt so hot that my fever went as high as 99.6 to  101.5 which last for whole day. And also this time I felt more weak from whole body ache and lost little bit of  my appetite
started menstrual bleeding two days after her 2nd Pfizer COVID vaccine. She continued to have menstrual bleeding for 21 days after her second shot. At that point, her Doctor prescribed an estrogen hormone which stopped the bleeding. Her cycle became regular again after the completion of 7 days of the estrogen.
Pt vaccinated w/Engerix-B 1-2 days post vaccine shoulder aches-joints of upper body - intervals had numbness, tingling fingers, felt bad lasted over six wks. NO MD treatment. 11OCT90 cont to have shoulder aches/joint discomfort.