chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on his chest, belly, waist line and the front of his neck in the middle area; his top lip is swollen; This case was reported by a consumer and described the occurrence of urticaria localized in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 11th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th March 2021, 1 days after receiving Shingrix, the patient experienced urticaria localized and lip swelling. On an unknown date, the outcome of the urticaria localized and lip swelling were not recovered/not resolved.   It was unknown if the reporter considered the urticaria localized and lip swelling to be related to Shingrix.  Additional information was provided as follows: The reporter was patient's spouse. The male patient received 2nd dose on 10th March 2021 and on the day of reporting his top lip was swollen and he had hives on his chest, belly, waist line and the front of his neck in the middle area. The reporter consented to follow up. Note- The vaccination date was provided in product section 11th March 2021 and in narrative it is 10th Mar 2021. However it is added as 10th Mar 2021 conservatively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021061356:same reporter US-GLAXOSMITHKLINE-US2021AMR061693:same reporter
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on an unknown date unknown number of unspecified patients at office had occasionally been administered with RECOMBIVAX HB (therapy start dates, dose strength, frequency, route was not reported) at schedules other than what is in the prescribing information for vaccination. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1408USA008513 via same reporter link. Additional information ha been requested.
Patient states he got his second injection on Friday and that his rash came  back over the weekend and stating this time the rash is worse. +Pruritis, trying  not to sratch. Denies fever/chills, HA, dizziness, cp, sob, dysuria, use of any  new soaps, toiletries, detergents, etc. Will treat locally with hydrocortisone and order benadryl and zantac given reported upset stomach.
Per Pt she got her flu shot on 10/14/2020 and starting 10/16/20 Pt noted body aches, fatigue and generally did "not feel well".   Pt is still experiencing hot/cold flashes and sweats.
Pt recvd vax & exp anaphyalxis; c/o burning of hand, dizziness & lost consciousness; pt taken to ER; profound hypotension; fatigue;
Incorrect dosage fro Age Group 12 y.o and up - Booster  sx: Fatigue and soreness from injection site
Loss/regression of communication abilities (mainly speech and language). Decresed eye contact. Social withdrawl. Frequent temper tantrums, unexplained/unpromptedemotional outbursts. Diagnosed with autism 8-2001. Diagnosed with static encephalopathy 1-2002.   60 day follow up states pt has not recovered. Autism and its related behavioral and medical symptoms (as described in 01/09/02 evaluation). We feel that the vaccine pt received on 11/29/1999 may very well have contributed to her current symptoms as well. Those vaccines were IPV Connaught P1213 MMR Merck 0555J Varicella Merck 1346I
more site reaction pain with Pfizer vaccine than modern vaccine; This is a spontaneous report from a non-contactable consumer via Pfizer Sales Representative.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on an unknown date at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  On an unknown date, it was reported that the patient experienced more site reaction pain with Pfizer vaccine than Modern vaccine. Outcome of the event was unknown.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained.
General weakness, intermittent numbness (especially bil hands), muscle twitching,  dizziness, headaches( general), diarrhea, back pain.
Two instances of uvitus, one requiring medical attention and medication. Had discomfort in her stomach and had an abdominal MRI which resulted in finding multiple pancreatic cysts. She's not sure if it's related.
pt recvd vax & w/in 4-5hrs p/vax exp irritated & reddened eyes;these adverse events lasted a few hrs, & was recovered by next day;
received an expired dose of Infanrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 19-SEP-2023, the patient received the 4th dose of Infanrix. On 19-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Infanrix vaccine).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Sep-2023 It was reported that a patient received an expired dose of Infanrix vaccine administered inadvertently which led to expired vaccine used. The reporter consented to follow up.
The night of the day I got the second dose of the Pfizer COVID vaccine, I felt like my stomach was on fire. I also felt really bloated. It felt like someone placed a sphere in my abdomen and then set it on fire. I tried eating, drinking water, and sleeping and nothing has helped. I have felt like this since then and it is currently 3/5 and I got the vaccine on 3/3.
every 15-30 minutes, patient's heart seems to flutter and feel almost like jello, almost like a hiccup or something; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 12:00 (Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history included known allergies to drugs: sulfa drugs and food: hazelnut, apple, peach. The patient was not pregnant at the time of report and vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ethinylestradiol, norgestimate (TRI-SPRINTEC); colecalciferol (VIT D3); and cobamamide (VITAMIN B12 [COBAMAMIDE]). Patient had no COVID prior to vaccination and was not tested for COVID post vaccination. It was reported that every 15-30 minutes, patient's heart seems to flutter and feel almost like jello, almost like a hiccup or something. Patient began to notice this on Sunday, the day after she was vaccinated, but it's possible that it could have been happening on Saturday as well. The patient did not receive treatment for the event. Event start date was reported as 11Apr2021 at 12:00. Outcome of the event was not recovered.
Continuing pain in left arm from date of vaccination on 2/24/2021.  No other side effects like fever. Took ibuprofen and used a heating pad. Went to PCP today and have prescription for MOBIC to help with discomfort and suggested icing and  movement of affected arm. Will get next vaccine shot 03/20/2021 at 8:20 am in right arm and hope that I don't the same side effect in that arm.  Is it possible to get the injection in a different muscle site?
Developed cellulitis in the left arm; Upper left shoulder is killing her hurts terribly; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) experienced cellulitis in the left arm/ cellulitis and the upper left shoulder was killing her hurts terribly/arthralgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Feb 2021, approximately five days prior to onset of the event, the patient received a dose of mRNA-1273 (batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient experienced the upper left shoulder pain and a medically significant event, cellulitis in the left arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events cellulitis in the left arm and the upper left shoulder was killing her hurts terribly was not reported.; 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.
No additional AE/PQC reported.; Caller reported vaccine administered after temperature excursion.; This spontaneous report has been received from a nurse and a consumer referring to an unspecified age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 13-JUL-2021, the patient was vaccinated with a 0.5 milliliters (mL) intramuscular dose of Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis (lot number T013205, was verified to be valid for syringe formulation; the expiration date was reported as 12-MAR-2021, but upon internal verification was established as 03-DEC-2021) (dose number, vaccination scheme frequency, and anatomical site of administration were not provided). The involved vaccine was exposed to a temperature excursion of 9.6 degrees Celsius during a time frame of 11 minutes, which was detected by a data logger (product storage error). No previous temperature excursions were reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Had the shot and still had the shingles/ Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine and still had the shingles. The patient stated that it was not so serious but enough for him/her and was no fun. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Recvd vax SEP86 & devel local swelling, fever, h/a, lt parotid mass below ear, muscle aches & pains, malaise, lump under jaw & some dental problems; biopsy of the parotid mass revealed benign sialadenitis & reactive lymphoid hyperplasia;
A report received from a health professional on 11/06/2002, concerning a 59 year old male vacinee who developed hives 3 days after receiving Fluvirin on 10/29/2002. On 11/01/2002 the vaccinee developed hives 3 days after receiving Fluvirin, the vaccinee did not have any other symptoms of an allergic reaction. The vaccinee treated himself with Benadryl. On 11/03/2002 the vaccinee recovered. There was insufficient information to determine the reporter's causality assessment.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored ZOSTAVAX vial 19400 PFU Lot # N020939 with expiration date on 26-OCT-2018 (dose was not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 8.2 Fahrenheit grades range for a time frame of 6 Hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA010635.
This spontaneous report was been received from a Nurse Practitioner refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unspecified dates, the patient was vaccinated with the first two doses of GARDASIL (strength, dose, administration route, lot number and expiration date were not provided). On an unspecified date, the patient received a dose of GARDASIL 9 (strength, dose, administration route, lot number and expiration date were not provided), and on 10-AUG-2016, the patient was vaccinated with the second dose (the fourth dose in the series of vaccination) of GARDASIL 9 (strength, and dose were not provided, lot number reported as M007764) subcutaneously. The nurse practitioner state it's not know when the patient received the previous doses of GARDASIL and GARDASIL 9. Additionally, no adverse effects were reported. Lot number M007764 in an invalid number for HPV. No product quality complaint (PQC) was involved. Additional information has been requested.
After receiving her vaccines, child was sitting on side of table; nurse noted that she looked very pale and went to lay her back; when she did that, she stiffened her arms and legs and her eyes were not focused; nurse had mother stay by child and she came to get me. When I entered the room, child was lying on exam table and crying. She was pale and diaphoretic and complaining of needing to go to the bathroom, her pulse was rapid but weak at that point, initial BP 70/p about 5 min after the onset of the symptoms. She continued to cry that she needed to use the BR but when mother started to sit her up, she became even more pale. Mother had a diaper in the room and she put that on her. After that, child was calmer and answered questions appropriately. Her BP was check ever 5 min and was better each time, her color returned to normal after about 10 min and she was able to sit without assistance. BP remained stable with sitting and she was then able to ambulate without assistance. She reported feeling great. She had some mild erythema at injection site but no hives or other rashes. MD talked with mom at 5:15, she has felt well the rest of day, no further episodes, is playing and has had no fever or other symptoms, told mom to call if any concerns.
Swollen lymph nodes in neck and shoulder.   Harmless. Time course: one has almost disappeared after five weeks, the other is smaller but may need a couple more weeks.
fever-highest at 100.2 oral temp, body aches, productive cough , headache-slight, shortness of breath with exertion, nasal congestion, chest congestion, chills, starting 11/29/21
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 38-year-old pregnant female subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis.  On 20 November 2007, the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 22 November 2007, 2 days after vaccination with Flulaval, the subject experienced extensive swelling of vaccinated limb, tenderness, erythema, rash and warm to touch.  The swelling occurred in the left elbow, slightly above the elbow area and into the lower forearm.  The subject went to the emergency department and was admitted to the hospital.  The subject was diagnosed with cellulites.  At the time, the events occurred the subject was 6 weeks pregnant and had not seen a gynecologist for a delivery date.  The subject was treated with amoxicillin trihydrate + potassium clavulanate (Augmentin (oral)) 875 mg twice daily.  At the time of reporting the outcome of the events were unspecified.
On tuesday night i had really bad sore throat, with body aches and chills. on the 6th i didnt have the chills any more but i had body aches and sore throat with a low grade fever of 99.8. I took some Tylenol the fever went down, but that entire day i had a headache that was really bad, with a runny nose and congestion, and my temperature would vary 99.4-100.The 7th the headache went away but i still had the congestion and coughing. that night the runny nose came back. and this went on until saturday the 9th. Late afternoon of the 9th the runny nose stop. the fever broke 99.7-98.2. The congestion has gotten better around the 12th. I stopped coughing the night after the 11th. I still have some congestion and a little runny nose yesterday.
Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Unable to Sleep-Medium, Additional Details: PATIENT IS IMMUNOCOMPROMISED, HE HAD HIS PRIMARY SERIES(3 DOSES), FIRST BOOSTER AND SECOND BOOSTER(0.25MLS) WHERE HE EXPERIENCED EXTREME SIDE EFFECTS UNLIKE PREVIOUS DOSES. HE HAD FLUID BUILD UP TOO IN HIS EAR WHICH LED TO VERTIGO
Rash noted on leg x 1 day, pink, red and lg macular area mildly sensitive to touch, pt place on Benadryl and schedule follow up visit in 2 days.
suspected vaccination failure; Shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (since puberty).   On an unknown date, the patient received the 1st dose of Shingrix. In February 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient suffers from shingles since puberty. The patient received 1st Shingrix vaccine in 2018. The patient received 2nd Shingrix vaccine in February 2019. After that the patient had shingles outbreak on leg. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting.
Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 22-DEC-2008, at age 64, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. On an unknown date, the patient was treated for the following injury resulting from his use of ZOSTAVAX: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Full body rash started at approximately 7am the morning after the shot. Raised bumps from neck to tops of hands and feet. Lines of rashes on back and trunk.
Pain in left shoulder that started the following day and has persisted for about 2 weeks. Pain is worse when lifting arm or picking up objects.
Within 10 or so minutes after vaccine,  I became very dizzy, then weak, my heart began to feel like it was going to pound out of my chest and so the nurse had me relax and said ahe could see my pulse through my clothing layers, they took my bp and it was really elevated (I don't have hypertension and I don't remember the exact number because I was kind of out of it)  I know the diastolic was over 110  maybe even 120 the first time.  My pulse was excessively high too. They called 911 and paramedics monitored me until my pulse slowed and softened some. My diastolic was still around 110. They allowed me to go home and lie down as long as I agreed to call them back or go to hospital if it didn't go below 100 after lying down a bit. It was 97 after about 40 mins,  then 95 after 1.5 hours, then 78 after 3.5 hours and 67 after 6 hours. I felt good again at that point.
Rash to right upper arm, abdomen after receiving his first injection.  He also complained of having shortness of breath and headache.
28 hours post  vaccine : fever of 101.2, headache,chills,fainting,nausea, arm sore,red. Systemic symptoms lasted 40 hours and resolved. Arm continued to swell and a hard, hot red lump developed. Redness expanded to cover entire upper arm. A hive like rash developed  day 2-3 and lasted for  3 days. Day 7  I contacted my physician and was told he doesn?t deal with COVID and vaccine issues.  Day 15-16 swelling and redness mostly resolved. Day 21 arm is still sore.
On 10.11.21 had a Fever of 101 and headache.  On 10.12 woke with hive looking all over body except face..hands and feet.  The hive have mild itch.  Mouth takes like metal.
12/29/21 presents to ED for "3-4 month history of headaches and abnormal behavior". PMHx of "Orthostatic hypotension"
Patient has had persistent pain and soreness in her L deltoid. She has difficulty abducting her arm. exam reveals tenderness diffusely along deltoid, no e/o cellulitis or abscess, no induration or erythema.