chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed body aches; Chills; Headache; 1st dose a year ago; Painful skin; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received a year ago, For tolerance of 1st  dose refer case US2022AMR179099).   On 23rd November 2022, the patient received the 2nd dose of Shingrix (intramuscular). In November 2022, 1 day after receiving Shingrix, the patient experienced skin pain. On 23rd November 2022, the patient experienced general body pain, chills, headache and drug dose administration interval too long. Rechallenge with Shingrix was positive. On 24th November 2022, the outcome of the general body pain, chills and headache were recovered/resolved. On an unknown date, the outcome of the skin pain was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the general body pain, chills, headache and skin pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR179099   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The reporter was the patient, she reported that she received the 2nd dose in the left arm. On the evening, she developed body aches, chills and a headache.  She reported painful skin.  By the evening of 24th November 2022, her symptoms had resolved.. The reporter consent to follow up. Consent to contact HCP given. Additional Supportive Information: The patient received first dose was a year ago and 2nd dose later than the recommended interval, which led lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2022AMR179099:Same reporter
Patient received first vaccine on 12/26/20 and it was a Moderna vaccine. Patient came for 2nd dose of his vaccine and received Pfizer by accident at our site. Patient was notified and states he had no unexpected side effects.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not  reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
a 7 month old patient was administered a VAQTA vaccine; No adverse effects; This spontaneous report as received from a medical assistant refers to a 7-month-old patient. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), (lot # R021233 has been verified to be a valid lot number, expiration date: 05-SEP-2019), (exact dose, route of administration, injection site were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no adverse event.
Information has been received from a health professional (reported as a nurse or a medical assistant) concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of GARDASIL.  Subsequently, the patient passed out in the office post vaccination.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
No adverse event; Improper storage of product in use; This spontaneous report refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies was not provided.   On 22-MAY-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, anatomical location and route were not reported) of (lot # 1621931, expiry date: 26-JAN-2022) for prophylaxis. It was reported that the vaccine was exposed to a temperature of 30.2 Fahrenheit for a time frame of 1 hour. There was no previous temperature excursion reported. Data logger was involved. No adverse effects were reported. No additional information provided. No product quality complaint (PQC) was associated with this report. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; 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
2-3 hours after my initial shot I had severe heart racing, palpitations and shortness of breath. They came in waves for about 10-20 minutes and stopped. 2 nights a later I had another short episode.
intermittent fever 100-102,  headache, malaise, irritability, some sort of rash on face (nose and cheeks), arms, hands, legs, feet, and a little on the back.
axillary lymphadenopathy supraclavicular lymphadenopathy chills, myalgias
I started experiencing what seem to be a rash on my arm, hand all the way up my arm. It seemed to get worse when I would go out in the sun. It lasted from January until about June.
With my first shot, my arm became sore 8-10 hours after the injection and stayed that way for about 24 hours. With my second shot (also in the left arm), I had the same reaction as the first injection; however, about 3 days later I woke up with a large lump under my left armpit. Over the next few days, I had swelling on the left-side of my left breast, swelling under the breast and below the left collarbone. This has been very painful, especially at night when I lay down. During the day, it seems to drain (relieving some of the pressure). As of today, I am 6 weeks out, and I still have some swelling on the outer left of my left breast. The lump under my arm has disappeared and the swelling under my collarbone has gone as well. Now I am dealing with sore muscles in my neck and shoulder on my left-side. I believe this to be because I could not hold my arm in a normal position for a number of weeks. My doctor ordered physical therapy for this issue.
Patient developed scant hives in office within five minutes of receiving vaccine. Hives were present on back and torso. Provider examined the patient and hives were beginning to resolve without intervention within an additional five minutes.  Mother called the office the day following vaccine administration (1/14/20) to report that hives had spread and become itchy - no respiratory involvement. Advised to administer Benadryl every 6 hours as needed for hives - patient to be seen if any lip swelling, pain, vomiting, or trouble breathing. Mother did confirm non of these symptoms were present, just the hives.  Mother called 1/15/20 to report hives on forehead, cheeks, behind ears, and persisting on back and torso. Patient seen in office for evaluation, prescribed prednisolone.
His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID.  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The caller said he's calling on behalf of his friend who has travelled with his family to France. His friend is 80 years old and his wife is 80 years old and the entire family including children and grandchildren have tested positive for covid on home tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The pharmacist said I might feel like I had a bad case of the flu and that's exactly what it felt like.  She told me if I was going to have a reaction it would occur about 5/6 hours after receiving the shot and then last for about 24 hours and she was spot on with the timetable.
Redness , swelling, hardened skin at site of injection.  One week later and it?s still swollen and hardened , but now it?s itching .
Narrative:  Timing ERROR only, 2nd dose given 46 days after 1st
Pfizer-BioNTech COVID-19 Vaccine   Nose bleed out of left nostril, lasted less than 5 minutes.
Patient told that after she received the shot  she felt dizzy and  feeling like blood rushing to head and felt warm near the neck and head. Symptoms were on and off and her blood pressure was high. Patient told that she felt this symptoms after few hrs.
pt mom states pt was listless, fever of 105; mom afraid pt would have sz-took pt to ER 6JAN93 PM; tx w/Advil & sent home; returned to ER 6JAN93 t106 adm to hosp devel rash; MD considers Roseola as a cause;
Vaccine stored in refrigerator after expiry date; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator after expiry date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator after expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator after expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Vaccines were kept in refrigerator on 22-Sep-2021.  The product had not undergone any temperature excursion.No adverse events were reported.  No treatment medication information was given.
Dose 5, booster; sore arm; 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 (BNT162B2), on 11Jul2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 11Jul2022, outcome "unknown", described as "Dose 5, booster"; PAIN IN EXTREMITY (non-serious) with onset Jul2022, outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Note: First Vax 4 weeks earlier (Moderna) made me weak with migraine for four days. This is a report of Second Vax (Moderna); Pain started at top of my head and wrapped it's way down the outside of my body. Then, the same pain event repeated itself  inside my body. Followed by fever, chills, migraine, dizzy, nausea, weakness? Which all continued for the next 24 hrs. I felt like I was being beaten with a baseball bat. That initial 24 hr event was followed by receding symptoms and lingering migraine over the next 3 days.
This case was reported by a healthcare professional and described the occurrence of sick in a 59-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 15 September 2011 at 16:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm) and experience expired vaccine used (expired May 2011). On 15 September 2011, less than one month after vaccination with FLULAVAL, the subject experienced sick. The subject who received the vaccine called out sick afterwards. At the time of reporting the outcome of the sick was unspecified.
Pt received a THIRD DOSE of Shingrix. Pt did not report any ADR when questioned after the fact.
12/19/2022 that evening I got up after eating dinner and I started having a very rapid heartbeat. It felt like someone was dribbling a basketball in my chest. I went to the emergency room. I had an EKG, bloodwork, was on a heart monitor and had an Echocardiogram. My heart rhythm was back to normal. I was diagnosed with atrial defibrillation. I stayed overnight so they could monitor my situation. I was seen by a lot of doctors. I saw a cardiologist that day and my heart rhythm was still normal. I was prescribed ELIQUIS and metoprolol which I am still taking. I was discharged home.
Tingling on the left side of her face radiating down her neck; She also began experiencing dizziness; Having a very sore arm that lasted 2 days after the vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   On 14th January 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In February 2022, 1 month after receiving Shingrix, the patient experienced tingling and dizziness. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the tingling and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, tingling and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The case was reported by the patient. She reported that after receiving vaccine in her left deltoid, having a very sore arm that lasted 2 days after the vaccine. About a month later, she began to experience tingling on the left side of her face radiating down her neck.  She also began experiencing dizziness. Neither of these symptoms were resolved. Healthcare professional information was provided. The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2022073187,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022073187:Same Reporter
Hives: large patches on torso with smaller patches on legs. First onset diminished over the course of the first day, with new but smaller spots appearing the following day. 2 BENADRYL tablets taken night of 10/15/2016, with a tablet taken the morning of 10/16/2016. Medication appeared to help prevent further spots appearing with no further irritations noticed as of 10/17/2016.
Pt came in today to receive their Pfizer booster. Pt was screened and immunized by one of our nurses. As we were entering the vaccination into the state registry, we saw that they received their second dose of Pfizer 12/9/2021 with a HCF (pt reported receiving it with us around November/December on the phone). This means they got their booster dose approximately 4 months early. Pt did not report any adverse events after their 15-minute waiting period.
Child received a bivalent COVID immunization at vaccine clinic. The dose received was not correct and may not adequately protect against COVID.  No adverse effects reported at this time.
Decreased-low eye contact, unresponsive to name being called, head-banging, stims like arm flapping, lining up objects, inappropriate play with toys, toe-walking, extreme tantrums, looking at objects through corner of eyes.  Diagnosed at Hospital with Autism in January 2008 and we began biomedical treatment January 2008.  8/10/09 Psychological assessment report received DOS 1/8/08 to 1/31/08. Assessment: Autism Spectrum Disorder. Patient presents with delayed speech/language skills, lack of social reciprocity, temper tantrums, repetitive behaviours. Daily functioning is lower than expected for age. Hand flapping and other stereotyped and rigid behaviors. Physical and neurological examination - WNL. Extensive developmental, language, and behavioral evaluation and testing. Mullen scales of early learning. Develpmental Profile II.
The morning after receiving the 23-valent pneumococcal vaccine, pt called PCP C/O pain, redness, and swelling in area of injection. He also noticed fever of 102 degrees. On arrival at PCP office, redness has spread down to arm with severe pain in shoulder proximal arm area with movement. Differential diagnosis included allergic reaction vs infectious cellulitis vs hematoma of muscular tissues. PCP prescribed loratadine and cotrimoxazole and instructed pt. to apply ice packs and keep arm at heart level. On follow up 4/28/17, pt. reported swelling had moved to bicep and elbow, pt. instructed to continue taking medications and call if not improved in 3 days- no further contact from pt.
patient was given intramuscular instead of subQ there was not adverse reactions and there was no need to  redo  it.
Patient seen in the ED and brought in by EMS on 7/8/22 after a fall at his senior assisted living apartment. Additionally patient was experiencing significant weakness and was tested for COVID-19 at an outside facility that day which was positive. Additional COVID-19 PCR swab done in the ED was also positive. Patient admitted from 7/8-7/15. During admission he briefly required supplemental O2 - about 1-2L O2. Patient has been vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Patient presented 5 hours after vaccination.  Unconsolable for 1.5 hours, no fever or redness at the injection site.  Hospitalized for observation.  Improved with Pain control following morning.  Warmth over the injection site but happy and content.
Pt was admitted to hospital from ED with A-fib on 4/5/21 after receiving the 2nd dose of vaccine on 3/30/21
Persistent severe migraine headache (mostly on the left side) beginning the day after the vaccine (booster dose), with nausea, dizziness, sensitivity to light and sound. I saw a doctor on day 4 for migraine, we tried NSAIDs, keterolac injection, sumatriptan, methocarbamol, valium, benadryl with no effect. For the first 24 days after the vaccine I had painful migraines for at least 14 days.  Sometimes the migraines are accompanied by aura (flashing lights, as well as visions of colors when eyes are closed). Usually I have nausea, diarrhea, bowel movements with the migraine, and severe neck pain and fatigue after. No prior history of headaches or migraines. The painful migraines have continued, almost daily until today (still ongoing). On average I have migraines 4-5 days a week. Sometimes I also feel scalp pain feels like someone is tugging on my hair. I also have a near constant pain or tugging feeling at the corner of my left eye, as though something is pulling the skin back towards my temple. I feel this pain in the corner of my eye almost constantly 24/7. I have since started a low-histamine and low-tyramine migraine diet, which has helped reduce the frequency of migraines slightly. This is because I noticed clear migraine triggers when I ate certain foods such as shellfish, or spicy food, for example. I had no prior history of headaches or migraines, or food sensitivities. I could eat shellfish and spicy food completely normally with no adverse effect before this.
Client states that he started have the following adverse reactions " 3days after receiving the vaccine(Moderna): 1. Vomiting 2.  Bloody diarrhea stools 3.  Dehydration
Vomiting, syncope, apnea, face looked pale, eyes rolled and trembling of hands, arms and mouth. Afterwards slept very heavily and was very hard to arouse.
Receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was given 2nd booster dose on 21-Apr-2022. Concomitant medication list was not provided. Treatment information was not provided.
Acute onset of fever (101.3), fussiness, and generalized urticaria within 30 minutes of vaccines. Treated with Benadryl and antipyretics.
Patient woke up on Saturday 6/5/21 with swollen lips. Symptoms got progressively worse throughout the day. Itching lips and ears. Hives on arms 6/6/21.  Patient stated she took diphenhydramine around the clock until symptoms resolved. Advised patient to follow up with her physician.
Chills for one hour at 4:00am on 3/21/21; Fever from 100.5-102.0 from 6pm - 11:30pm 3/21/21; Advil
Myalgia, Fever, NauseaVomiting, chills, sweats, fatigue Narrative: