chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of depression in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced depression). At the time of the report, depression outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Information has been received from a physician concerning a female patient with no pertinent medical history and no known allergies who on an unknown date was vaccinated with a second dose of GARDASIL (Lot # not reported). Concomitant therapy included isoniazid, 2 months prior to getting first dose of GARDASIL, had been on isoniazid for 4 months total. A few days after receiving the second dose of GARDASIL, the patient experienced diffused muscle pain, arthralgia, knees hurt, difficulty with joints and had headaches. The physician believed significant disability because the patient "could not function anymore and not getting out of the house". The physician also mentioned that the patient did not have any problems after the first dose of GARDASIL. The patient sought medical attention by an office visit. A "blood work" test was performed which was normal. At the time of the report, the outcome of the patient was not recovered. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, lot numbers and date of event. No further information is available.
Patient experienced cough, sore throat, headache, and runny nose on 4/27
This spontaneous report was received from a registered nurse regarding an 18 year old female patient. Information on the medical history and concurrent conditions of the patient were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M011117, expiry date 07-DEC-2016, (dose#, units, route and anatomical location were not reported). Concomitant medication were not reported. On an unknown date, mother of the patient reported that the patient had "some swelling of her arm and a rash for approximately two days after the GARDASIL 9. Outcome of peripheral swelling and rash is unknown. There were no additional side effects reported. No additional information available. Additional information has been requested.
No other AE reported; A temperature excursion on ROTATEQ that was administered 2 times; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 22-SEP-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1684163 was verified to be valid, expiration date was reported as 20-JUN-2021 but upon internal validation was established as: 26-JUN-2021) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The reported stated that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered two times. The temperature to which the vaccine was exposed was not reported. It was unknown if previous temperature excursion occurred. It was not reported if a digital data logger was involved. No adverse symptoms were reported.
Moderate joint pain all joints both hands, light rash on abdomen.  Taking acetaminophen extended release tablets, 650 mg, 2 at a time, every 8-10 hours.
Hives all over the body starting 1-2 days after vaccine. hives look red or pink, above skin. Most are small in 1-2 mm diameter.  Fell itch. No fever. Have had it for 3  days
Extreme aching of the joints in my hands, now one week after injection.  Occasional aching still in my upper arms.  Finally took some Tylenol Thursday 2/4 evening and the aching went away.  Wasn't associating hand pain with the COVID vaccine :(  Aching is back today, Friday 2/5.  Only submitting this because I don't have a spleen and maybe it might help others.
Breakthrough case admission after three vaccines Moderna 3/3/21 Lot# 025A21A;  Moderna 3/31/21 Lot# 028A21A;  Moderna 11/23/21 Lot# 012H21B
Developed clustered, painful  blistered papules down right arm the morning after my covid booster. The next day even more developed in a line cluster down my arm. With swollen lymph nodes in my armpit. Sunday evening a rash began on my right scapula towards my spine. Began taking Advil/Tylenol as the area was very red and painful and used cortisone on the papules without relief. Attempted to be seen my employhealth at work Monday but was unable. The papules continues to swell and create significant pain. Finally was able to see employee health on Wednesday and was diagnosed with shingles.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX. It was reported that the patient had a perianal rash that was painful and the patient also developed nerve pain. The physician reported that the rash did not resemble shingles. It was not made clear if the rash occurred before or after vaccination. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007; 12/21/2007. Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX (Merck). It was reported that the patient had a perianal rash that was painful and the patient also developed nerve pain. The physician reported that the rash did not resemble shingles. It was not made clear if the rash occurred before or after vaccination. A product quality complaint was not involved. Follow-up information received from a healthcare professional indicated the patient is an 80-year-old male with perianal rash, rectal pain, back pain, insomnia, pulmonary hypertension, cardiac failure congestive, coronary artery disease, type I diabetes mellitus, peripheral vascular disorder, weigh loss, edema, pruritus ani, irritated dark lesions over forearms, tinea cruris, acute upper respiratory tract infection, diarrhoea, an allergy to amoxicillin and AUGMENTIN, sulfamethoxazole and LESCOL XL who on 21-MAR-2007 at 11:45 was vaccinated subcutaneous in the right deltoid with a first dose of ZOSTAVAX (Merck) (lot # 656412/1476). On 05-FEB-2007 the patient had a perianal rash that increased after adminsitration of ZOSTAVAX vaccine (Merck). The patient has had some relief with use of LYRICA 100 (unit not reported) TID and has been evaluated by gastrointestinal "GI". At the time of the report the patient status was not recovered. Additional information has been requested.
Fever with fussiness 4 days after immunizations, large red bump on left thigh 10 days after immunization.
Pt stated within 4 hours of receiving this as her first every flu shot that she was "itchy all over".
Seriousness criteria: Other-Medically Significant. Initial report was received from the patient on 16 July 2008. A 60 year-old female patient with a history of heart disease, blood pressure, hip problems, and allergies to DARVON and sulfa, received an intramuscular right deltoid injection of DECAVAC, lot number U1962AB (invalid lot number) on 10 July 2008 and 10 minutes later, she developed dizziness and her skin turned red and was described as sunburn color (the symptom "skin turning red" was also reported with an onset 45 minutes later), 30 minutes later, she had one episode of vomiting. The redness persisted four and a half hours. The patient also developed a fever of 102 degrees Fahrenheit and bruising at the injection site. On 16 July 2008, nausea still persisted and the patient reported some shortness of breath. The patient stated she had felt sick ever since. The patient received corrective treatment with PROMETHAZINE 25 mg. She had no illness at the time of vaccination and had been receiving concomitant medications which consisted of HTZ, LOPRESSOR, VICODIN, NORVASC, baby aspirin and VALIUM. The patient spoke with her physician and her physician informed her that "he didn't do anything wrong so it must be the medication". The patient also stated "there was a recall of some of the vaccine and although her lot was not recalled it makes her nervous". At the time of the report, the patient had not recovered from the event.
I got shot 7-27, 7/29 I had itchy bumps on face, when I got home, hives all over my legs, I took 1 BENADRYL. 7/30 still there but not itching.
Within the next day he was Very lethargic, went from happy smiling baby to blank. Within a month after he  no longer had eye contact. In his own world. Didn?t respond to his name. No longer waved or clapped his hands. 4 months later banging his hands and blanket into his head. Black circle bags under his eyes. Swollen like eye & seemed sick. Started showing signs of autism.
Hospital Course   Pt is a 83 yr old male with a past medical hx of HTN, hyperlipidemia, CAD, CABG, Afib, DM, BPH, appendix cancer was admitted to Hospital on 12/11/21 with a co cough and shortness of breath for 3 weeks. Pt was diagnosed with COVID19 infection.   1. COVID19 infection: symptoms of 3 weeks duration on admission - CXR showed lung basilar atelectasis - Ferritin/CRP  557/8 on admission - COVID19 infection with viral pneumonitis - Pt too late for Remdesivir - Pt in cytokine storm - Pt given one dose of actemra on 12/15/21 - on acyclovir 400 mg BID for 4 weeks for HSV prophylaxis post actemra till 1/12/22 - Pt completed 10 days of dexamethasone,  - pt intubated on 12/20/21 - on airborne  isolation - no clinical evidence of sepsis - id/pulmonary / intensivist service on consult -Patient was also treated for acute kidney injury electrolyte abnormalities -In spite of aggressive and trended treatment patient respiratory status is in general condition worsen and patient expired after CODE in 12 /22/ 21
Breakthrough case admission after three vaccines Pfizer 2/19/21 Lot#EN6200;  Pfizer 3/12/21 Lot# EN6207;  Pfizer 10/6/21 Lot# EW0183
0.3 ml dose was drawn up from Pediatric Pfizer vial and administered to patient. Patient received 0.3 ml of the Pediatric Pfizer vaccine instead of 0.3 ml of the adult Pfizer. The patient was notified as soon as it was discovered and advised to return to get 0.3ml of the 12+ adult pfizer vaccine Patient returned on 12/02/2021 and was given the replacement dose of 0.3ml of the adult pfizer vaccine Lot number 30145BA expiration 12/31/2021 to Left deltoid No adverse events were reported.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 168 doses were given  from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up was received.
Sometime in early November I started feeling mildly ill, I originally thought it was cold/flu type. However, I never got any normal symptoms, no fever, aches or pains, congestion, etc. All I got was a horrible cough, mostly dry where I felt like I was trying to cough something out of my lungs, the cough was so violent and long-lasting that I would occasionally lose consciousness from it. It eventually became where I was getting mucus up but the cough persisted and has been a problem still over 2 months later. Currently I get the cough maybe 1 or 2 times a day.
Patient developed myalgias, arthralgias, fever within 48 hrs of vaccination (vaccine given 2/8). At two weeks post immunization, he developed brief diplopia and ataxia. Admitted to acute care hospital on 2/23/18: MRI was Negative, but LP showed 146 WBC (48% PMN) and Mildly elevated protein (60). All cultures are negative thus far and ME PCR panel was negative. Awaiting Yellow Fever PCR and IgM assay on CSF (sent to CDC). Strong suspicion of Yellow Fever Neurotrophic Disease. Patient is doing well, and was sent to short-term rehab on 3/5/2018. Significant anxiety overlay.
Patient lips begin to swell 20 minute after receiving  covid19 Vaccine.  Patient had left clinic and returned due to the swelling of lips. At the time of return swelling to lips were slightly visible with some redness. Client refused treatment of benadryl intramuscular due to driving to site. She stated she felt fine after additional observation period of 30 minutes. Vital signs Heart rate 89  BP 132/64  Sp02 98% Resp. 18 . Followed up with client on 02/04/2021. Client stated she took OTC benadryl once returning home w/ no complaints today.
I had a severe sore and congestion, body aches, cough it felt like a common cold, maybe a little worse. I used a home COVID-19 test and it came back positive. I called and had a telehealth visit with my doctor who prescribed the Paxlovid. As soon as I started taking the Paxlovid my sore throat went away the next day. I was feeling much more like myself in about eight or nine days.
Neighbour lady had a blood clot in her back and was paralyzed from her waist down two weeks after her first shot; Neighbour lady had a blood clot in her back and was paralyzed from her waist down two weeks after her first shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: THROMBOSIS (medically significant), PARALYSIS (medically significant), all with latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "Neighbour lady had a blood clot in her back and was paralyzed from her waist down two weeks after her first shot". Clinical course: Reporter reported that her neighbour lady had a blood clot in her back and was paralyzed from her waist down two weeks after her first shot. She was now in a nursing home.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021192614 same reporter/drug, different patient/events;
Narrative: Patient reported syncope after receiving 2nd dose of pfizer covid vaccine. States has syncope after any vaccine, blood draw, etc. Patient was able to depart without any intervention.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "PCOS" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2022, stop date: 01Aug2022; MONTELUKAST, start date: 01Jan2022, stop date: 01Aug2022; ALLEGRA, start date: 01Jan2022, stop date: 01Aug2022; ADVAIR, start date: 01Jan2022, stop date: 25Jul2022. Past drug history included: Known allergies: morphine, reaction(s): "Known allergies: Morphine"; Known allergies: vicodin, reaction(s): "Known allergies: Vicodin"; Known allergies: demerol, reaction(s): "Known allergies: Demerol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has taken Paxlovid for the treatment of COVID-19 from 25Jul2022 to 29Jul2022. The patient has experienced adverse event on 26Jul2022 at 01:00 AM, Recovering, treatment received: IV Fluids. The patient developed extreme diarrhea and nausea by the second day on Paxlovid. He spent two days in the ER being evaluated. His covid symptoms also did not fully resolve during treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history, relevant concomitant medication, and past drug history were unknown. On 26-NOV-2014, the pharmacy had a power outage and the temperature in the refrigerator reached 77 degrees for up to 9 hours. On 28-NOV-2014, a dose of PNEUMOVAX 23 (dose and route were not reported, lot # K009874, expiration date: 19-MAR-2016) that was stored in the refrigerator was administered to a patient. It was unknown if there was relevant lab data. Additional information has been requested.
Productive cough, green sputum, vomiting, sore throat, headache, fever, chills, sinus congestion, and lethargy. No treatment recommended by Physician.
Caller's physician is recommending GARDASIL 9 to treat her warts.; This spontaneous report was received from a consumer referring to herself, a female patient with unknown age. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patient's physician was recommending hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot# and expiration date were unknown) for her warts (product prescribing issue).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005480:
Bells palsy, patient tested + for covid at the time of my evaluation, she is symptomatic and was symptomatic at the time of the vaccine.  pt developed right Bells palsy 2 days after vaccine given
Disorientation; Dizziness; left upper eyelid swelling; This spontaneous case was reported by a physician and describes the occurrence of DISORIENTATION (Disorientation), DIZZINESS (Dizziness) and SWELLING OF EYELID (left upper eyelid swelling) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DISORIENTATION (Disorientation), DIZZINESS (Dizziness) and SWELLING OF EYELID (left upper eyelid swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 29-Mar-2021, DISORIENTATION (Disorientation), DIZZINESS (Dizziness) and SWELLING OF EYELID (left upper eyelid swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided
PT REACTION: APPROX. 10 MINUTES AFTER INJECTION, PT FELT FAINT.  MOTHER STATES PT ASKEG HER TO HOLD HIM, SHE NOTICED HIS EYES ROLL BACK AND THEN FELL INTO MOTHERS ARMS.  PT IMMEDIATELY REGAINED CONSCIOUSNESS.  PT WAS MONITORED AT PHARMACY FOR AN ADDITIONAL 15 MINUTES AT WHICH TIME PT WAS ABLE TO STAND AND WALK ON HIS OWN. VAERS REPORT COMPLETED.
GARDASIL vaccine, 3rd dose, administered 5/2/12. Child seen on 5/4/12 9 cm x 10 cm area of (L) upper arm red and hard warm to touch but without cellulitis or lymph involvement.
pt recv vax 14JUN95 & pt exp gen joint swelling mostly of the lower legs & ankles, & an urticarial rxn;reporter stated that this was the 2nd rxn of this type p/ceclor;
This medically confirmed spontaneous report (initial receipt: 09-Oct-2012) concerns a 3-year-old patient. On 09-Oct-2012 the patient was vaccinated with AFLURIA (batch number was not provided) injection intramuscularly. No known adverse effects were reported.
Patient states that she received vaccines around 4:30pm, afterwards she did feel tingling in her left arm but didn't think much of it.  Around 6:30pm the tingling (tightening of skin feeling, states hard to describe) become more pronounced down left arm, body and leg.  States she went to ER around 8pm for tingling in arm and body, throat closing up and sweats.  States she was there till around 12:30am, they just observed her.  No medication was given per patient.  States she received a prescription for a "steriod" but hadn't taken it yet.  Just took OTC Benadryl when she got home from the hospital.  States a lot of the symptoms resolved just feels exhausted and achy.
Bump; Arm swelled; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled) and SKIN MASS (Bump) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (Arm swelled). On an unknown date, the patient experienced SKIN MASS (Bump). At the time of the report, PERIPHERAL SWELLING (Arm swelled) outcome was unknown and SKIN MASS (Bump) had not resolved.            Concomitantly the patient was taking unspecified medication for his heart disease (unspecified).  No treatment information was provided by the reporter.
Pt vaccinated w/DTP/OPV cried unconsolably for >3 hrs. , Temp 99.6.
Sig and painful axillary lymphatonopathy. Still present on 10/12/22@ 2100. No associated erythema, malaise, fevers or chills. No other lymphadenopathy.
11/22/2001 post vax, the patient developed fiery erythema, hot to touch, palpable hardness and extreme pruritus of the lateral aspect of the upper arm from the acromiun process to the elbow. On 11/23/2001 the patient experienced body wide pruritus with diffuse, reddened blotchy areas body wide. The patient self-medicated with oral Benadryl. On 11/28/2001 the injection site had a 6cm area of diffuse redness. The patient complained of mild to moderate pain at the injection site. The other symptoms were resolved.
Headache, Myalgia, NauseaVomiting,  Fatigue Narrative: