chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US016691 is an initial spontaneous report received from the physician assistant on 19 Aug 2014 with a follow up report received from the physician assistant on 30 Sep 2014. This report refers to a 13 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with one dose of MENVEO (batch number: X12004/A12004) intramuscularly on 04 May 2014 and with another dose of MENVEO (batch number: A12004) at a dose of 0.5 ml, intramuscularly into her right deltoid on 19 Aug 2014 at 12:00 PM respectively (inappropriate schedule of vaccine administered). On 19 Aug 2014, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: T25EG) at a dose of 0.5 ml, intramuscularly into her left deltoid. It was reported that she initially experienced itching at the injection site, diarrhoea, upset stomach and was sleepy after vaccination which caused her to rest her head. She also had an episode of nose bleed. On an unspecified date, she was hospitalized for an unspecified duration and she completely recovered from the events. She was seen by a PCP after a week which coincided with her yearly visit and no adverse events were noted during the visit. The reporter spoke to the patient's father after a few days and the patient was reported to be fine. The events were reported as serious (hospitalization) and causality of the events was not reported. Follow up report was received from the physician assistant on 30 Sep 2014: Updated the date of vaccination of initial dose of MENVEO, the anatomical site of vaccine administration and time of vaccination of the latter dose of MENVEO, co-suspect vaccination, events (diarrhoea, upset stomach and nose bleed), seriousness and causality of the events, outcome of the events and reporter's comments.
ZOSTAVAX given in error to 4 year old in addition to VARIVAX. Should have received MMR and varicella. No unusual side effects reported.
He took Pfizer Covid-19 vaccine on Friday (7AM) and Friday afternoon (around 5 PM) he started itching and noted itchy rash on the body Saturday. Saturday morning he had a lot of pain in the shoulders and he took Tylenol. He also took antihistamine (?Loratadine) on Saturday.
Patient developed deep arm pain soon after vaccine that persisted for multiple days.  Days after vaccine, arm became red and warm  This has persisted to today (1/20).  Has not worsened.
Had shingle shot, still got shingles/suspected vaccination failure; Shingles; Painful; Uncomfortable; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingle shot, still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Painful) and discomfort (Verbatim: Uncomfortable). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. The patient stated that it was painful and uncomfortable. The patient was told that to receive another dose of shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Severe depressive episode with tearfulness. suicidal ideation. Lack of motivation, psychomotor retardation. confusion I  negative thinkinghave not had this severe depression for at  least 10 years.  Previous curent depressions 4 hours or so, easily dealt with  Severity startin better after 4 days, Currently still not at baseline, sad,
severe reaction; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (severe reaction) and DYSPNOEA (difficulty breathing) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Bronchitis (always had bronchitis frequently since he was a child).   On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (severe reaction) and DYSPNOEA (difficulty breathing). At the time of the report, IMMUNISATION REACTION (severe reaction) and DYSPNOEA (difficulty breathing) had resolved.            After the Moderna Booster the patient had a very severe reaction. He had difficulty breathing for 2 weeks, he was doing fine. The patient had the Moderna vaccine each time. The patient had always had bronchitis frequently since he was a child, this might be a preexisting condition.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I had a blood shot eye (right). Two weeks later, both eyes became inflamed and red. I went to Optometrist on 5/11/2021 and went back a week later 5/18/2021 - the second time they said to see a Retina specialist. I thought I was having vision problems, They changed my prescription and I still couldn't see. My eyes were becoming progressively more blurry. Eyes were blood red and the water was pouring from my eyes by that point. I went to center - 4th of June and saw a nurse practitioner. She diagnosed me with an eye infection and nonspecific conjunctivitis - eye drops (extremely painful to take they burned my eyes)  - Also, antibiotic for the infection. 6 days later my eyes were worse after using those eye drops and I had to stop using them. He put some other drop in my eye and said I had a tear in my iris (that ended up being the wrong diagnosis) and said I need to go to Ophthalmologist. The Ophthalmologist said it was Uveitis - Inflammation of the eye. Generally caused by an auto-immune disease. She got me to see a Retinal Specialist. She gave me a prescription for eye drops (expensive) Durezol - and almost immediately I could see immediately (I wasn't driving by that time) but my eyes were still red.  Dr is a retinal vitrius specialist  he agreed to continue on with the expensive eye drops;  he ordered almost identical bloodwork as the ophthalmologist - to get immediately - it was testing me for auto immune disorders. I went back three weeks later - I still have to see him again. She said the bloodwork came up unspecified - no underlying auto immune disease. It came on so suddenly and it lasted a good 2 months. The last two doctors saved my eye sight. The drops from the medical center were not for what I needed. I had to undergo 3-4 weeks of expensive eye drops. There were days when I would have to go to a darkened room - that's how badly inflamed they were. I go back to see the Retinal Specialist. Pain is gone but  I don't get the flashing light in the corner of my eyes anymore.  2nd dose April 14, 2021 - Lot #EW0161.
Shingles Dec/2000, Shingles June/2003, Shingles Aug/2008
vial was first punctured on 7/21 at 11:12 a.m.  was used to vaccinate patient on 7/22 at 11:20 a.m.  This is over the 24 hours  that Pfizer can support  11 minutes after 24 hours was less than 1% of a 24 hour period which is likely relatively insignificant.
This side effect randomly happens to me 2-3x/year, I wasn't overly concerned and just watched it. I have no idea what triggers it so it may not be vaccine-related  Vaccine: 9am. About 25 minutes after the vaccine (9:25am) , my lips started tingling and went numb. Within 10 minutes or so, the tingle/numbness travelled to my entire face and inside my mouth and tongue. I waited 90 minutes then self-treated with two Benadryl tablets (11am). Tingle/numb were gone 1-1:30ish.
29 hours after injection, minor fever; 23 hours after injection, extreme exhaustion; All muscles felt week; general tired feeling.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 23Feb2021 at 01:45 PM (age at vaccination was 47 Years) as DOSE 1, SINGLE for COVID-19 immunisation at workplace clinic. Medical history included Covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. No allergies reported. Concomitant medications includes vitamin d3, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) and probiotics; taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid tested post vaccination. 23 hours after injection, on 24Aug2021 at 12:45 PM, the patient was experienced extreme exhaustion set in. All muscles felt week. On 24Aug2021 at 06:45 PM, 29 hours after injection, minor fever. 40 hours after injection, exhaustion and fever were resolved and the patient just had a general tired feeling on an unspecified date in Feb2021. The report was non-serious. The patient was not received any treatment for adverse event. Outcome of the event tiredness was unknown and remaining events were recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Resident became increasing lethargic to minimally responsive in the days following the vaccine. While at an unrelated neurology appointment she had an episode of apnea and tachycardia. The neurologist stated that there were no evident since of recent stroke and she was likely suffering from symptoms related to the vaccine. In the days following she was administed to the hospital for uncontrolled A-fib with a pulse range of 120-180, and she was unresponesive. She was sent back to the nursing home after a 7 day stay with the dx of A-fib and no further explaination of her symptoms. She was somewhat responsive upon return, but not at her baseline. Over the course of the month she had difficulty swallowing or taking medi
patient states night of vaccine (3/31) she had cold chills, On 4/1 she felt "chilly cold" all day and had upper leg muscle pain/weakness
Patient is 63 years old and fluzone high-dose (for 65 year old and older) was given. so wrong flu shot was given to incorrect age group. Called him and he is ok and no side effects or adverse reactions.
On 3/6/99, the pt experienced a rash and a fever of 101.9. The pt recovered on 3/8/99.
Fever of 105 degrees axillary approximately 16 hours after administration.  Acetaminophen given with subsequent drop in temp. to 100.5 degrees.  No lethargy or limpness noted.  Child feeling fine with no temp after 24 hours.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negetive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Anti viral with Paxlovid. Paxlovid rebound, contracted COVID again 5 days after finishing paxlovid, two days after testing negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse referring to multiple unknown patients of unknown age and gender. Information about pertinent medical history and drug allergies was not provided. On multiple unspecified dates, multiple unknown patients were administered improperly stored GARDASIL 9 (lot#/ expire date: L036301/20-DEC-2017, lot#/ expire date: M024261/30-JUL-2018, dose and frequency were unknown) for prophylaxis. The temperature of storage for GARDASIL 9 was 22 Celsius for 5 minutes. This alarm happened while plugging in the Data logger. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004318: US-009507513-1612USA004317: US-009507513-1612USA004315: US-009507513-1612USA003676.
Information has been received from a pharmacist via a company representative concerning to a 69 year old female patient with no pertinent medical history. On 10-OCT-2016, (reported as "3 days ago") was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapies included gabapentin. In October 2016, the patient experienced an injection site reaction which consisted of a warm lump and swelling in the injection site. There were not lab diagnostics studies performed. The patient visited the pharmacy and the pharmacist recommended the patient to take ADVIL or TYLENOL for treatment. There was no intervention to prevent serious criteria. No cancer, death, disability, hospitalization, life threatening or overdose were reported. At the time of the report the patient felt better and the reaction had resolved. No product quality complaint was involved. The relationship between injection site reaction and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Mom called requesting son's 12 record with manufacturer and lot number. Stated her son was DX and Autism and believes there is a link between immunizations provided and diagnosis. Stated she requested to have single antigens. Mom stated she would complete report herself.
Starting the day following the injection (3/8/19) headache, muscle aches, general malaise, tiredness, shivering.  Resolved by the following day (3/9/19).
I don't know if it has been reported. My 92 y/o mother was given 5cc of the flu vaccine instead of 0.5cc in her arm. She has been lethargic since and now is on comfort measures. This was reported to me by staff at the nursing home.
her whole body is sore & aching, and hurting real bad/ Muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (her whole body is sore & aching, and hurting real bad/ Muscle pain) and ARTHRALGIA (joint pain) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 028K21A and 067T21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (her whole body is sore & aching, and hurting real bad/ Muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MYALGIA (her whole body is sore & aching, and hurting real bad/ Muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medication were provided
Left arm has redness, swelling and itchiness in the area of the injection Treated with over the counter ibuprofen.
PATIENT REPORTS A "REACTIVATION" OF WASP STING FROM AUGUST 11, 2023 ON THE WRIST AREA OF VACCINATED ARM. SHE SAYS IT IS IN THE EXACT SAME SPOT AND IS VERY SWOLLEN, RED, AND ITCHY.
Within an hour I wasn't feeling well. My stomach was in knots and I felt nausea. My arm was hurting a little but I was ok. 9 days later I threw up a lot and I don't normally throw up. I couldn't move. I was seriously ill. I didn't know where I was, my family came and took care of me. I was so sick, I couldn't get back to bed. I was hallucinating, lost of memory
hives/welts; She also has had lumps on her head like pimples under her hair; Swelling of the throat; severe itching; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives/welts), ACNE (She also has had lumps on her head like pimples under her hair), PHARYNGEAL SWELLING (Swelling of the throat) and PRURITUS (severe itching) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives/welts), ACNE (She also has had lumps on her head like pimples under her hair), PHARYNGEAL SWELLING (Swelling of the throat) and PRURITUS (severe itching). At the time of the report, URTICARIA (hives/welts), ACNE (She also has had lumps on her head like pimples under her hair), PHARYNGEAL SWELLING (Swelling of the throat) and PRURITUS (severe itching) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Patient  got her first dose in September, then another one in December, though unsure which year. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Had hives on the (R) deltoid, on the shoulder/clavicle, on back, described them as big red itchy. Patient took BENADRYL has recovered.
Less than 40 min after receiving MMR #2 and VZV #2, and KINRIX (DTaP #4, IPV-polio #4) child developed streaming eye, clear rhinorrhea, coughing, "tight" chest - bronchial constriction with wheezing, tongue slightly thickened and thickened voice. Initially given diphenhydramine 25 mg po for watery eyes, then given EPI PEN 0.15 mg for resp. symptoms.
Whole body inflammation, tingling and pain from neck to fingers down right arm. Also, hives from right forearm to elbow.
Information has been received from a healthcare worker referring to unspecified number of patients (age and gender were not reported). On unspecified dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K020216, expiration date 17-SEP-2016, lot # K026666, expiration date 22-OCT-2016, (dose, dose #, route and application site were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/29/21 and 4/26/21. Covid sx's began 2/24, home test + 3/1. Presented to ED 3/9/22, hypoxic at SpO2 50% on RA. Admitted for acute hypoxic resp failure 2/2 Covid PNA, c/b  AKI, pancytopenia, and pulmonary edema. Initiated on HHF: SpO2 95% on FiO2 80. Hypoxemia progressed, required intubation 3/14. Suffered cardiac arrest 3/18/22, received ACLS/CPR for approximately 25 minutes but never attained ROSC. Treated with remdesivir,cefepime, azithromycin, flagyl, tociluzimab and solumedrol.
swollen painful lymph nodes; swollen painful lymph nodes; Minor pain at injection site; mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 06Feb2021 10:30 (Lot number: EM9810) at the age of 55 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Stage 3 Breast cancer-Left", start date: 01Mar2006, stop date: 07Jan2007, notes: 2 Lumpectomies removed all lymph on total thyroidectomy RA 131.; "Tall cell thyroid cancer", start date: 17Mar2014, stop date: 01Sep2014; "total thyroidectomy RA 131" (unspecified if ongoing); "Lumpectomies" (unspecified if ongoing); "Chemo Radiation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Lot no: EL3249, Anatomical location: Arm right), administration date: 16Jan2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "Minor pain at injection site", "mild headache". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Feb2021, outcome "recovered" (2021), described as "Minor pain at injection site"; HEADACHE (non-serious) with onset 06Feb2021, outcome "recovered" (2021), described as "mild headache"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 07Feb2021 08:00, outcome "recovered" (2021) and all described as "swollen painful lymph nodes". Therapeutic measures were not taken as a result of vaccination site pain, headache, lymphadenopathy, lymph node pain.  Additional information: The vaccine was administered in a Public Health Department. The vaccine administration date was also reported as 02Feb2021. The events did not result to admission to a hospital or a visit to emergency room or physician's office.   No follow-up attempts are possible. No further information is expected.
Fever for two and a half days anywhere from 99.7 - 104.2. Chills, headache so bad I thought my brains would come out of my ears for two days. Third day, chronic, annoying light headache. Dry mouth and esophagus that required me to drink a lot of water for the first night. Redness and swollen the size of baseball at injection site. No appetite. Reaction was twice as bad as the first injection. Eyes burning.