chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm with local reaction - swelling, erythema, mild warmth. Hydroxyzine HCl 25 mg TID prn. Treatment: KEFLEX 500 mg BID x 10 days, prednisone 20 mg TID x 2 days.
pt presented to hospital after a fall earlier today, c/o abdominal pain, confusion, fatigue and decreased appetite x 1 wk; tested positive for COVID; condition deteriorated where pt passed away in the hospital.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue Narrative:  Other Relevant History:
pt recv vax 24APR97 & 2 days later pt exp a large localized rxn;
Information has been received from a male consumer with no reported pertinent medical history, drug reactions or allergies who "9 months ago" in approximately June 2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included COUMADIN, statin (unspecified), blood pressure medication and "elcarnatine." The patient reported that his waist area became painful and sensitive to touch shortly after receiving zoster vaccine live (Oka/Merck). The patient also noted that the pain began two days after starting therapy with elcarnatine (manufacturer unknown). The lot number was not available. Unspecified medical attention was sought. At the time of reporting the patient had not yet recovered. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Called Connections on 4/20/21. Pt c/o feeling swollen throat glands, hard to swallow, dry/sore throat, also random dizziness not constant, feeling body aches, tired, runny nose but pt denies sob, difficulty breathing, chest pain. Speech seems comfortable, AO X 3. Pt stated these sx started on 04/13/2021 after he got his Janssen(J&J) covid vaccine on 04/12/2021,he stated sx not getting better its getting more from then. This writer recommended pt to go to ED/call 911 for further evaluation and treatment. Pt took covid test yesterday awaiting for his result. Denies any past medical Hx
Initial unsolicited report received from a patient on 07-Mar-2017. This case involves a 55-year-old male patient who was vaccinated once with 0.5 ml dose of FLUZONE QIV via intramuscular route (batch number: UI829AD; site of administration, expiry date not reported on an unknown date of Dec-2017. The patient's medical history and concomitant medications were not reported. On an unknown date of Dec-2017, immediately after the vaccination, the patient had pain in his whole body that he felt was worsening. On an unknown date, after the vaccination, patient cannot sleep at night and he lies on his couch during the day screaming from the pain he reports racing thoughts, unable to rest at any point. Patient required emergency room visit several times. Laboratory data and corrective treatment was not reported. Patient did not recovered from the events. List of documents held by sender: none.
I'm about seven months out from second vaccine. I didn't have heart issues before vaccine. I have had heart pain since second vaccine. It first started with mild flutters in the weeks after the second vaccine. Then it got severe with stabbing pains mostly when I was either laying down or going on walks. I am unable to sleep or lay on my left side or on my stomach. I have constant heart pain and at times stabbing heart pain. Unable to do anything cardio wise besides mild cardio or else an increase in symptoms. Ibuprofen seems to make it worse. I have gained about 10 percent in weight in last six months due to way less activity since I can't regularly exercise. Even taking my dog on walks is painful some days. Primary care doctor kept telling me it would get better after a few months as he'd seen other patients with similar issue after vaccine.
Dizziness, vertigo, especially when standing up from sitting ir sitting up/standing up from lying down
3.5 cm X 5 cm, erythema induration, left deltoid, red, hot itchy
per medical report from hospital- "presented to emergency room at outside facility secondary to worsening shortness of breath. The patient states that about 1 week ago she started feeling ill directly after receiving her first covid vaccine. the patient states her medical issues actually began approximately 2 months ago when she developed sudden onset positional urinary retention as well as urinary incontinence and constipation. She states that she thought maybe her known spinal stenosis had worsened causing her bladder dysfuntion.She states she tries to sit on a commode or a toilet and is unable to void however when lying flat she has to wear adult briefs as she has no control over her bladder at all. There is no p
16MAY94 12noon persistent crying for 3-4 hrs, t101.6, vomiting which was projective x 2 on 16MAY93; golf ball size swelling & redness @ inject site on 16MAY94;
Has not received the second dose; Active Herpes Zoster; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 9th July 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The first dose was administered at a different facility so pharmacist did not have the lot number or expiration date information.  The reporter reported that on the same day of vaccination, patient was diagnosed with shingles and till the time of reporting did not receive the second dose, which led to incomplete course of vaccination. The reporter gave permission for follow-up.
Patient noticed redness and swelling and aching the day after the shot.  He administered ice pack and took advil.  Redness and warmth spread over 48 hours, the swelling went down day 3, but the redness and warmth continued to spread.  The swelling was about 5 inches in diameter.  He went to the walk in clinic on day 4 (today)  and was diagnosed with cellulitis.  The dr. prescribed an antibiotic which he will take tonight.
On day nine after the vaccine administration, I developed a rash and pain at the injection site.  I can submit a photo if needed.
Generalized puritis with 3.5 x 3.5 erythema and warmth at injection site.  No SOB or difficulty breathing.  Occured within 20 minutes of injection
No adverse event; We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, 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 28-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live significant follow up included patient information, suspect product start date, batch/Lot no and expiration date information added.
05jul90 pt vax 2nd hepta B. 12 hrs following vax pt devel n/v/d
Narrative: Patient received 2 doses of covid vaccine. Patient was recently in hospital before death. PMH includes decompensated cirrhosis, ascites, melena. Patient has no documentation of death recorded. No documentation of concern of covid vaccine relating to death. Reporting per network instruction.
Covid arm.    Arm has rash, swelling and taunt hard large lump , skin is hot to touch and itchy..   begining days after injection
pt recvd vax; exp severe swelling of arm & redness, warmth, pain & soreness at inject site;
During the day I was super tired and headachy. I went to bed for the night and I woke up 2 hours later and felt nauseous and like I was going to throw up. Super stuffy nose. 2 hours later I woke up again with chills and sweats that continued for hours and I was nauseous again.
Immediately started smelling toxic smell, has been almost a year and still is smelling toxic smell. Happened with 1st and 2nd dose, got better and came back with booster.
pt recv vax 10DEC97 & 36 to 48hr p/vax pt exp generalized hives;
Pt recvd 3rd dose of Hep B vax on 25NOV91 & lab eval on 21JAN92 showed no detectable Hep B surface antibody; No further details were provided;
a dose of PENTACEL was administered without reconstituting with the HIB portion of the vaccine, reporting only the DTAP/IPV portion was administered with no reported adverse event; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old male patient who had a dose of pentacel was administered without reconstituting with the hib portion of the vaccine, reporting only the dtap/ipv portion was administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); and rotavirus vaccine (Rotavirus vaccine).  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine lot UJ551AAA via intramuscular route, expiry date- 05-Aug-2022 in unknown administration site.  On 28-Mar-2022 the patient had a dose of pentacel was administered without reconstituting with the hib portion of the vaccine, reporting only the dtap/ipv portion was administered with no reported adverse event (single component of a two-component product administered) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
onset of pain in LUE 2 hrs p/vax; rash evening of 27OCT; erythematous, macular, swelling, fever & pain in LUE;
Pt developed substernal chest discomfort 20 minutes after vaccination.  Transportation to ED and ED evaluation advised but patient refused.
Vertigo/room spinning; Blurry vision; General "fuzzy" head feeling; Headache going from back of head (left side) to the front.; Had a small rash that has since turned into the bruise; Had a small rash that has since turned into the bruise; Bruised knot at injection site still hasn't cleared; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196) via an unspecified route of administration, in the left arm on 01Jul2021 (at the age of 28-years-old) as dose 1, single for COVID-19 immunization at pharmacy or drug store. The patient medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication within 2 weeks of vaccination included ESTRADIOL, 0.5mg once daily taken for an unspecified indication, start and stop date were not reported. Allergies to medications, food, or other products included dilaudid and lortab. Prior to vaccination patient was diagnosed with COVID-19 and did not received any other vaccines within 4 weeks. Since the vaccination, the patient had not been tested for COVID-19. On 01Jul2021, the patient experienced headache going from back of head (left side) to the front started within an hour of receiving the vaccine and hadn't stopped since, and Still ongoing; and also had Bruised knot at injection site still hadn't cleared and had a small rash that has since turned into the bruise. On 03Jul2021, on day 3 after vaccine patient had Vertigo including blurry vision, room spinning, and general fuzzy head feeling started and lasted until day 7. The reporter assessed the events as non-serious The patient did not receive any treatment for the event. Outcome of the events vertigo, blurry vision and general fuzzy head feeling was recovered on 07Jul2021 and outcome of other events was not recovered.
Seizure - I have never had a seizure before and there is no history of epilepsy in my family. I had the Janssen vaccine shot at around 5PM on Thursday and felt mostly fine on Friday. I had typical shot symptoms (tired and soreness near injection sight). On Friday night around 10:00, I was standing talking to one of my friends in the living room when I had a blackout seizure without any warning. The seizure only lasted about 30-45 seconds, and then I became conscious again. It took me about 5-10 minutes to become completely aware and able to stand up. I have never had a seizure before and have not had one since then.  Later the following week, I did have a couple of hours where I felt extremely dizzy and lightheaded, but it went away without another seizure. This is also not typical for me.
Patient fainted Approx 10 minutes after vaccine. Paramedics in store - transported to hospital.
4hr p/vax devel fever to 102 & h/a given APAP;was 3rd dose of hep b;no prev rxn;
ALLERGIC HYPERSENSITIVITY; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine (live, attenuated)) (batch number KJ2502) once/single administration, via nasal route, on an unknown date. The patient had previously received 1 dose(s) of Flumist.     On an unknown date, the patient experienced allergic hypersensitivity (preferred term: Hypersensitivity).     The outcome of the event was unknown.    The event was considered non-serious.
This spontaneous report was received from a certificated medical assistant and refers to 2 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 29-AUG-2016, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L038503, expiration date 18-DEC-2017 (dose, frequency, route of administration were not reported). The patients' concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
No additional adverse effect reported; Nurse called to report that on 22-JUN-2020 a patient received a dose of improperly stored PROQUAD; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not provided.  On 22-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) by subcutaneous route (PROQUAD) (dose, vaccination scheme, and anatomical site of vaccination were not provided) (lot number S031704 have been verified to be a valid, expiration date reported and validated as 06-APR-2021) as prophylaxis (product storage error). It was mentioned that the sterile diluent used was properly stored (lot number T001631 have been verified to be a valid, expiration date reported and validated as 11-JUN-2022).  The administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in a temperature of -9 degrees Celsius (C) to 8 C (-8.3 C), for a time frame of 20 minutes. There was no previous temperature excursion. It was reported that a digital data logger was involved. No adverse effects were reported.
Me / have got Shjngles after being vaccinated / Suspected Vaccination Failure; Me / have got Shjngles after being vaccinated; Can still my shingle "rash" areas; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she had got shingles after being vaccinated. The patient did not get it as bad. The patient had no open soars, but after 3 years could still his/her shingle rash areas. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case has been linked with US2021AMR095125, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095125:Same reporter. Master case -Others-.
Nauseated feeling returned; Feeling yucky and rotten; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling yucky and rotten), NAUSEA (Nauseated) and NAUSEA (Nauseated feeling returned) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling yucky and rotten) and NAUSEA (Nauseated). On 07-Feb-2021, the patient experienced NAUSEA (Nauseated feeling returned). On 24-Jan-2021, FEELING ABNORMAL (Feeling yucky and rotten) and NAUSEA (Nauseated) had resolved. On 09-Feb-2021, NAUSEA (Nauseated feeling returned) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Red circle/rash size of half dollar surrounding injection site. Headache, lethargy. Slight swelling of lips.  Lasted approx 2 days after noticing on 6/13. No treatment needed. Symptoms resolved on their own
Mother of infant received 2nd dose of Pfizer 9/21. Mother actively breast feeding infant. 24 hours after mother receiving 2nd vaccination, infant had significant bradycardia (drop in heart rate), desaturation ( low oxygen in the blood causing infant to turn blue). Infant was a previous 31 weeker adjusted to 36 weeks and discharge was pending at time mother received 2nd vaccination. After the initial episode, infant required a feeding tube due to feeding difficulties and lethargy. Infant was monitored in NICU with continued episodes of feeding difficulties associated with choking, inability to coordinate suck/swallow/breath, and bradycardic events. Head ultrasound was completed to show multiple cysts/hematomas (blood clots) present on the brain that were not present prior to vaccination. Infant was transferred to higher level of care for neurological evaluation. Due to absence of hematomas prior to vaccination and no evidence of head trauma, and  the known  vaccination side effects of potential blood clots; this shall be considered an adverse event.
This spontaneous report was received from a physician refers to a 62 year old female patient with drug reaction/allergies to ZOLOFT, CRESTOR, PRAVACHOL, ZOCOR, DIOVAN, AMBIEN, BONIVA, PAXIL, ADVAIR and NASACORT AQ. The patient's medical history included hyperlipidemia, primary insomnia, sinusitis and muscle cramps. On 05-SEP-2009 the patient was vaccinated with ZOSTAVAX 0.65 ml vial, (lot number, expiration date, and route were not reported). Concomitant therapies included omeprazole, CARDIZEM, metronidazole cream, LIVALO, NASONEX, PULMICORT, aspirin, MAXIDE, folic acid, ALLEGRA, XANAX, EVISTA, vitamin D, calcium and CENTRUM multivitamins. The physician informed that on 31-JUL-2014, the patient had a rash on her upper right side of her back. She stated that her neck was hurting and burning. The patient was given a diagnosis of shingles. The patient was prescribed VALTREX and was given an injection of DEPO-MEDROL with lidocaine in the physician's office. The outcome of the event was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Entire ride side from head to toe began swelling about 2 hours later. 24 hours later there was some swelling on the left side of the body.  48 hours later a rash apperead mostly on the right side of the body.  72 hours later there is a red band around my arm where the injection site is. Have had a really nad headache since the night of the shot.  Throat has also been hurting. Right arm feels like it's going to pop.  Right eye and nose are swollen.  Having trouble breathing through my right nostril.  Right neck has been stiff since the night of the injection..