chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 7th August 2018 19:00, the patient received SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 8th August 2018, the patient experienced headache and hypersensation skin. On an unknown date, the outcome of the headache, hypersensation skin and pain in arm were unknown. It was unknown if the reporter considered the headache, hypersensation skin and pain in arm to be related to SHINGRIX. Additional information was reported as follows: On the day and in the evening of the vaccination, the patient's arm became painful. The next day after vaccination, the patient developed headache and his skin felt sensitive to touch but the patient did not experience any rash or swelling on the skin. The patient did not specify where the skin sentivity was present.
Developed Covid-arm: raised, warm to the touch, red area at site of injection  on the morning of 01/18/2021 .  Later that evening broke out in hives from my hips to my ankles.  Spoke with my allergist who said it was most likely an inflammatory response from the vaccine and to treat with Benadryl.  Took Benadryl and hives were gone by the next morning.
no issues until 7 days then shoulder/joint pain in left arm that has continually worsened.  Presently cannot raise arm above shoulder without pain
pt recv vax & w/in 24 hrs of vax pt exp a 3inch diameter lesion @ the inj site w/erythema, pain, swelling, warmth, & swelling of arm & fingers; No further details were provided;
MOM NOTICED LARGE REDDENED AREA AT INJECTION SITES ON UPPER RIGHT ARM (PREVNAR) AND UPPER LEFT ARM (COMVAX).  LUMP FELT UNDER REDDENED AREA.  REDDENED AREA FELT WARM BUT WAS NOT TENDER TO TOUCH.
06/03/21 Pain in right lower leg.  06/05/21 increased pain, swelling and redness.  Seen at urgent care. RX keflex 06/07/21 Increased pain, swelling and redness with red streak going up leg.  RX: eliquis for 1 week. sent for lab work. and ultrasound 06/21/21 worsening pain, swelling and redness with bruising from calf to above the knee. 07/01/21 same symptoms now up to groin.  Referred to vascular doctor. restarted blood thinner (eloquis) 07/07/21 seen by vascular surgeon.  Continue blood thinner and return in 3 months.
6/11/14 Fever and chills;  6/14/14 evening-chills, hot, hard, painful red rash anterior, lateral and posterior upper arm at site.  Took Benadryl 50mg x1 with slight relief.  Rash continues anterior and lateral with pain 5/10 but getting better.
suspected vaccination failure; whooping cough; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 83-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to dTpa vaccine.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The patient received dose of dTpa vaccine 4 years prior to the reporting and she continued to get episodes of whooping cough. The patient asked was there a better vaccine for her. The patient stated that she got recurred cases of whooping cough and she need a better vaccine than the dtap. The patient also asked could GlaxoSmithKline help her. The patient stated the booster dTpa was not giving her protection. The dTpa booster given to her in the Hospital when she was discharged. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Immediate shooting pain in upper arm and shoulder that continues even at rest and has now been 5 hours since injection and there is throbbing pain in left wrist as well. Tylenol and Aleve do not alleviate pain at all. Pain so severe it causes nausea (even before taking any OTC pain relievers).
Event occurred after dose completion. Patient was diagnosed with Covid Vitamin c, Zinc sulfate, Tylenol Inpatient
rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rash.
Pt. states that she received the flu shot. Shot was placed in right upper  arm. Following the shot, pt. reports intermittent pain and numbness/tingling to right upper extremity. Reports a burning sensation to whole arm, which is intermittent. Also reports a "constant pain" from elbow radiating up to pinky and ring finger on right hand. Radial pulses 2+ bilaterally. Weakness noted to right hand.
Initial case received from a health care provider on 5/3/2006. An 18 year old male patient, with no past medical history, had received an injection of Menactra, lot number U1662AA and Tubersol 5 TU, lot number C2214AB, on 5/2/2006. Routes and sites of administration were not reported. Upon driving home post vaccination, the patient fainted and had a car accident. Per the reporter, no further details available at this time. At the time of this report, the patients recovery status was unknown.
localized redness to area 1 x 1 1/2;general swelling to rt thigh;asymmetrical gait;pt states is painful to bear weight;no tx required;
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, reported as between 12-AUG-2016 and 20-AUG-2016, the patients were vaccinated subcutaneously with doses of improperly stored (Oka/Merck) VARIVAX (lot # 019127 with expiration date on 27-MAY-2017; dose and anatomical location were not reported), which were exposed to temperature excursions. No adverse effects were reported. The details of the temperature excursions are: 1st excursion (date unspecified): 13.1 degrees Fahrenheit for 48 hours 2nd excursion (date unspecified): 11.5 degrees Fahrenheit for 1 hour and 52 minutes. This is one of several reports received from the same reporter. Lot number 019127 is an invalid lot number for (Oka/Merck) VARIVAX. Additional information has been requested.
I have hearing problems two weeks after the Moderna first shot.   My right ear is ringing and the hearing is muffled.  I also had pressure in the right ear.   I did take  Ibprofin and the pressure was reduced.   I  have had the ringing and muffled hearing for 4 weeks.
Information has been received from a physician and a licensed Practical nurse concerning an approximately 12 month old male patient with a "family history of dairy allergy" who on 25-JUL-2011 was vaccinated with a dose of VARIVAX (Merck) (Lot Number: 667232/1607Z; Expiration date: November 2012). Suspect therapy included a dose of MMR II (Lot Number: 667867/0790Z; Expiration date: May 2012) and a dose of VAQTA (Lot Number: 670835/0628AA; Expiration date: March 2014) on 25-JUL-2011. The physician reported that the patient developed a 103 fever and had a seizure. The nurse reported that on 26-JUL-2011 the patient's grandmother reported that the "patient's hands were starting to twitch and his eyes rolled back in his head". The patient was transported by rescue to a hospital where the patient had a temperature of 103.4 F and heart rate of 195. The hospital lab results appeared normal and the patient was discharged on 27-JUL-2011. The patient sought medical attention. It was reported that the therapy would not be reintroduced. At the time of the report, the patient's present status was unknown. Additional information has been requested.
Patient reports she was itchy the morning after vaccination and noticed a rash appearing on 03/04/2021 with worsening rash symptoms on 03/06/2021. Patient reports she waited until 03/08/2021 to see if rash would resolve, when it did not she report she went to  Urgent Care,  to checked. Patient reports UC provider treated her for allergic reaction and gave her a IM injection; which patient reports has helped her symptoms tremendously.
Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:34 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 60.98 years.  Concomitant products were not provided.  On 15-Apr-2021, 18 vials were moved to clinic.   On 06-Apr-2021, the vaccines were moved to fridge.  Proposed beyond use date was 09-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
She also had the bleeding under control; She also reported having a period for a week when she has been in menopause for 10 years; She has been having on and off fatigue; Nausea; Headache; Bloating; This is a spontaneous report from a contactable consumer (reported for herself). A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25May2021 (at the age of 59-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 04May2021 (at the age of 59-years-old) as 1st dose, single dose for covid-19 immunisation. On an unspecified date, the patient reported that when it started to go downhill. She had been having on and off fatigue, nausea, headache and bloating. She experiences these for 3-4 days out of every week. She has self-medicated with Aspirin and Tylenol. She also reported having a period for a week when she had been in menopause for 10 years. She also had the bleeding under control as she also self-medicated as she cannot get a hold of her gynecologist and it has been frustrating. it has been 6 weeks. The patient is asking whether if this is normal and how long will she experience these. She also added that she doesn't have a primary health care physician and only a gynecologist. Therapeutic measures were taken as a result of events with Aspirin and Tylenol. The event the She also had the bleeding under control was assessed as serious (medically significant). The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
I tested positive for covid on July 10 i experienced sneezing, coughing, sinus drainage and i was also prescribed plaxlovid for my symptoms.
8/10/2021 - presents to ED with cough, SOB and weakness for a couple days - Started decadron and remdesivir, requiring 2 to 3L O2 8/12/2021 - on room air, still coughing a lot and difficult to experctorate mucous 8/14/2021: pt stable and on room air, thrombocytopenia stable
Patient felt unwell and had a fever on Wednesday (1/27) and went home early from work. On Thursday morning (1/28), she threw up once and then laid down to rest. Her son reported seeing her that morning with the episode of emesis prior to her getting on the couch. Son reports that when he came home at 5pm, she was asleep on the couch. Teenage daughter reports patient had been asleep on couch all day. Son tried to wake patient up and she was disoriented and lethargic.  Daughter (reporter) was contacted to come see patient and on arrival to house (5;45pm), noted patient was confused, lethargic, febrile (104), and hypoxic at 83% on room air with portable pulse oximeter. Patient was able to stand and ambulate to car with assistance and was driven to Emergency Department for evaluation.   At emergency department, patient was hypotensive 80/40s but was able to increase blood pressure with 3 L of normal saline to blood pressure of 90/50s. See all tests performed and results below.  Patient received antibiotics, anti-virals and tylenol for fever of 102.7 while in emergency department. She was admitted to ICU that evening at approximately 11pm and had a foley catheter placed overnight due to decreased urine output. patient continued to have low blood pressure through morning of 1/28 and was placed on levophed for blood pressure control at approx 10 am. Her blood pressures continued to improve through afternoon and levophed was titrated down and then discontinued around 4pm.  She continued to received antibiotics for 24 hours after initiation and continued acyclovir during course of hospitalization and is still receiving doses on 2/2. Patient's initial mental status was confused, lethargic, and unable to communicate. She was intermittently oriented to herself only and would not follow commands. She would localize painful stimuli. Her mental status began to improve on Saturday when she started to become more awake but was still unable to follow commands or communicate clearly. She was moved from ICU to IMCU (step down unit) on Saturday once mental status was improving and blood pressure was stabilized. Her mental status continued to improve from Saturday 1/ 30 to Tuesday 2/2 (current). She began to have diarrhea on Saturday afternoon that continued through Monday and occurred every 1-2 hours. She was unable to stand or move body on her own and had to be assisted by staff to be cleaned. She remained awake and alert and was able to get up and walk on Monday and began to eat. She continued acyclovir treatment pending HSV meningitis panel PCR results (still pending currently 2/2). Mental status not currently at baseline but continuing to improve. She is also still experiencing generalized weakness. Hospitalist team and infectious disease doctors report she should be discharged tomorrow (2/3).  No source for confusion and hypotension has been found at this time. Physician team think HSV is unlikely but awaiting final diagnosis until test is resulted.
104 degrees, acrocyanosis, peri-oral cyanosis, prolonged capillary refill, one episode of loose stool. Normal UA, Renal panel/glucose and CBC. Blood and urine culture negative. Treatment: 20 ml/kg IV NS bolus, IV Ceftriaxone. Pt returned to normal in 24 hrs.
Terrible body aches and headaches. Felt like couldn?t even walk at times. Extreme tiredness. Slept for 20 hours straight. Took 3 Tylenol. Lasted about 30 hours total. Ended abruptly the next day but tired like symptoms seem to be remaining as well as some forgetfulness.   Did not go to hospital or go for treatment.
Participant had been visiting their father, two siblings had been in a play and someone in the play with them contracted COVID. The play had started Thursday and by Friday others in their household had started getting symptoms of COVID. On Sunday one parent tested positive and then Monday the other tested positive. Only the participant and the parents tested positive which was Tuesday, the other two siblings never tested positive and they had the same booster date and lot number on their doses.
Pain at my jaw joint approximately one week after the second injection. I could not open my mouth without pain. Once I could open my mouth, I could not close it without severe pain. This continues to today but has become less severe of an issue.
She received her first COVID-19 vaccine (Pfizer) on 7 Oct 2021 (Lot: FF2589) in the L arm. She reports no symptoms during the initial 15 minute waiting period but as she was leaving the waiting area after that observation period, she felt nausea with a cold sweat and dizzy. Around that time she started to notice some tinnitus of the L ear. She went home and went to bed and the following morning noted myalgia and joint pain. The following day she noted persistence of the tinnitus, now involving both ears. Since that time she has had episodes of tinnitus, about 4-5 times/day in both ears. She reports no ear pain or subjective hearing loss. The myalgia, joint pain, nausea and chills noted above have resolved.
4 Apr 08 - Shingles shot suggested by doctor even though I had shingles in 2001.  Received shot, rash broke out on wrist and ring finger first.  Self medicated until 7 May 08 - went back to doctor.  He said he didn't know what it was, but gave me Zyrtec and cortisone cream.  Did not work, so went to dermatologist - not to base.  She said it was no itching, but scabs.
Awoke, baby was hot and had a fever of 104 under the arm. Mother saw body jerk and flinching, but she was conscious. Next day child was breathing heavy and still had a high fever.
102.5 fever, chills, severe headache, body aches, nausea, vomiting, arm pain and swelling
Persistent Dry Cough; This is a spontaneous report from a non-contactable other health professional (HCP). A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced persistent dry cough on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021); administered with an expired vaccine which was beyond 30 day use by date per manufacturer; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine which was beyond 30 day use by date per manufacturer) and PRODUCT STORAGE ERROR (Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021)) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine which was beyond 30 day use by date per manufacturer). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine which was beyond 30 day use by date per manufacturer) and PRODUCT STORAGE ERROR (Vaccine was also beyond the 30 day use by date (initially placed in the refrigerator on 13Dec2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that this was the patient's 1st booster dose.  It was reported that the vaccine was also beyond the 30 day use by date and was initially placed in the refrigerator on 13-Dec-2021. Vail did not undergo any temperature excursions. No concomitant medications were reported. No treatment information were reported. Safety follow up was not obtained by the agent.   Reporter did not allow further contact
Suboptimal dose given < 0.5cc. Error due to incorrect dosing when drawing up. Unclear if pt got a full dose. In concern and in an abundance of caution, advise will need to revaccinate, explain at lengths that he is not fully vaccinated and VE may be less and he would be at risk. Discussed options at length along with risk and consequences. Pt questions answered, will decide after to get re-vaccinated. No concerning sx when discussed on phone. Only sx is having flu like sx.
Prolonged tinnitus in right ear about 6-12 hrs after vax.  Hearing first got weird in the right ear - sounded muted, and could hear a lot better in the left ear.  Then, tinnitus started continuously for about 2 hours. After that, it was on and off periodically until bedtime.  The tinnitus was gone by the next morning.  I normally very very rarely get tinnitus, and usually for no more than ~2-10 minutes.