chrisvoncsefalvay/vaers-outcomes huggingface dataset:
didn't feel like to do anything/, just lying down; pain at the injection site; fever ranging form 100 -101; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (didn't feel like to do anything/, just lying down), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (fever ranging form 100 -101) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced ASTHENIA (didn't feel like to do anything/, just lying down), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (fever ranging form 100 -101) and HEADACHE (headache). At the time of the report, ASTHENIA (didn't feel like to do anything/, just lying down), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (fever ranging form 100 -101) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: 100-101f (High) outcome was unknown.         Concomitant medication was not provided Treatment medication include Tylenol .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
On 03/05/2001 the patient experienced a chicken pox outbreak, around 32 pox. The patient did not have a fever. The patient did not have known contact with wild type chicken pox. Additional information has been requested. Per F/U 6/18/02: Info has been received from a health professional concerning a 4 year old male child with no known medical history or allergies who on 4/25/97 was vaccinated SC in the right arm with a 1st dose of varicella vaccine (lot 622681/0087E). There was no illness at the time of vaccination. On 3/5/01, the pt developed a chickenpox outbreak (around 31 pox) over 24 hours. The pt had a fever and itching. Pt did not have known contact with wild type chicken pox. There was no relevant diagnostic tests and lab data. Subsequently, the pt recovered. Additional info is not expected.
It was reported from an article published on 29-JUN-2009 that there were 27 deaths in 2008 said to be associated with GARDASIL. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
high fever now 102.4°F; This is a spontaneous report received from a contactable consumer (patient's wife) via a Pfizer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unknown date as 2nd dose, single for covid-19 immunization. On an unknown date (this happened after the second dose of vaccine), the patient was experienced high fever now 102.4 degree F and already taken paracetamol (TYLENOL) for fever. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from the registered nurse refers to multiple, unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored RECOMBIVAX HB (lot # L019298 and expiry date: 22-JUN-2017, lot # L029631 and expiry date: 14-AUG-2017, lot # L016427 and expiry date: 13-APR-2017, lot # L018501 and expiry date: 22-JUN-2017) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
9:20 Pt reported to individual not feeling well.  FNP and EMS to pt--pale, diaphoretic and sitting in chair.  Unresponsive-breathing without difficulty.  Pt aroused in appx 10 sec and assisted to WC and wheeled to medical eval tent.  Pt A&O, no SOB/CP.  Pt reports she "does this (syncope) once in awhile-the doctors don't know why"  The pt also reports she has " done this" (syncope) in the Dr.s office before as well.  They just laid my down".  Denies no treatment or dx given for episodes.  EMS evaluated with VS-Stable.  Pt drinking water bottle without complications.  Pt declined to be transported to hospital for further evaluation.9:50 apprx pt independently amb to OBS area with supervision.  escorted pt husband to her in.  After a few minutes-pt reported doing well when asked. Color evaluated and WNL-no paleness and/or sweating noted.   Discussed with pt and husband at next appt for vaccine: 1-eat something prior-pt reported she did not eat today 2-let someone at medical area of today's episode and to lay down prior to vaccination 3-Husband may come with pt at next appt 4-next appt is location change and will be at Pt also instructed to contact her PCP and report today incident. Both individuals verbalized understanding and ambulated independently to exit steady and without difficulties.
having high temperatures; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a physician (under reference number: US-SA-SAC20210303000497).  This case involves an adult female patient who experienced having high temperatures (pyrexia), while she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious having high temperatures (pyrexia) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Swollen lymph nodes to the left side of body; nauseous; increased pain in joints and muscles; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes to the left side of body), NAUSEA (nauseous) and ARTHRALGIA (increased pain in joints and muscles) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes to the left side of body), NAUSEA (nauseous) and ARTHRALGIA (increased pain in joints and muscles). On 15-Jun-2021, NAUSEA (nauseous) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes to the left side of body) had not resolved and ARTHRALGIA (increased pain in joints and muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were mentioned. No treatment details were reported. Swollen lymph nodes on the left side of her body  became more pronounced after the second dose.
pt recv vax 24APR97 & the following day pt exp fever (unspecified), axillary lymphadenopathy, myalgia, malaise & a sore shoulder;there was no hx of allergies, nor were other vaccines administered to the pt @ this time;
2/15: Red rash, swelling, firm, itchy, warm  to touch. Approximately 3 inches in diameter; 2/16: red rash spreads, doubling in size,  still itchy. no medication taken; 2/17: no significant change.  Late afternoon, experience left shoulder ache, headache.  9:00pm 1 tablet  500mg Tylenol taken; 2/18:  red rash spread; itchy along edges.  2:00pm 1 tablet Benadryl taken; Headache 10:00pm 1 tablet Tylenol taken; 10:30 pm 1 tablet Benadryl taken 2/!9:  swelling, red rash diminished by 60%.  Slight itching.  Still not resolved.
Patient came back on Sunday 10/07/2017 complaining of could not move her arm, or change her clothing.
fever, noc sweats, red, raised bumps itchy, to head, back, bilat  arms & legs, rt breast area;
Left leg became very swollen and hot to touch.  Taken to urgent care on 8/26/11 and diagnosed with cellulitis.   Also, on 8/29/11 developed red rash on entire body.
51 yo F who was not known to have had chicken pox and was varicella antibody negative was vaccinated with Varivax (varicella Zoster) vaccine on 1/26/2023 at 1019.  Lot # W022605. Placed SC in right arm.  Patient called clinic 2/8 due to soreness with some vesicles at injection site and on her shoulder.  Video visit set up for 2/10/23.  Patient reported an area on her face at that time.  MD assessed and determined patient had vesicular rash.   No fevers or chills. May have had a mild headache.  Reaction consistent with a mild vaccine reaction and not a true varicella infection. Reassurance given. Patient does not need to isolate and can receive the second vaccine in the series.
Right arm very swollen at injection site. DX localized reaction to immunization. Was told to ice it and give Tylenol.
Patient had redness, itchy, and hot around injection site that appeared 6 days after injection.
Information has been received from a registered nurse concerning a female patient who was exposed to her grandmother who on 08-FEB-2008 was vaccinated SQ in the right arm with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). Medical attention was sought on 24-MAR-2008 in the clinic. The patient had shingles. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was treated with acyclovir 400mg. The patient's outcome was not reported. Follow-up information indicated no new information. Additional information is not expected. This is one of several reports from the same source.
Patient presented to the ER on 3/28/2021 with shortness of breath and lower extremity edema and complaining of lower back pain. O2 sat high 80s on room air. Worsening renal failure since last discharge from hospital on 3/23/2021.   Patient was readmitted to hospital from skilled care facility after being discharged 5 days prior with acute on chronic stage IV kidney disease as well as acute on chronic diastolic heart failure and had slowly worsening with renal dysfunction and growing concern for dialysis.   Patient had developed a cough, a fever up to 101, and 1 questionable sewed of either hemoptysis or hematemesis since being discharged to skilled nursing facility on 3/23/2021. Patient was transitioned to the hospice team and expired on 4/2/2021.
red rash covering a small area of the arm; maybe hive; the area is a tiny puffy; arm was itching terribly/very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash covering a small area of the arm), URTICARIA (maybe hive), SKIN SWELLING (the area is a tiny puffy) and PRURITUS (arm was itching terribly/very itchy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced RASH ERYTHEMATOUS (red rash covering a small area of the arm), URTICARIA (maybe hive), SKIN SWELLING (the area is a tiny puffy) and PRURITUS (arm was itching terribly/very itchy). At the time of the report, RASH ERYTHEMATOUS (red rash covering a small area of the arm), URTICARIA (maybe hive), SKIN SWELLING (the area is a tiny puffy) and PRURITUS (arm was itching terribly/very itchy) outcome was unknown.            Patient stated that after the first to doses they had nothing. No concomitant medication were provided. No treatment information were given.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Non-Significant Follow up- Updated contact information
Got severe itching 5 or 10? after vaccine. No hives. Itching started in hands, radiated up arms to neck and face. Equal itch bilateral (not any more severely itchy on left side/ the side she received shot). Took 25 mg Benadryl 35? after vaccine, helped severe itch in 10?.
4 days after 2nd dose of vaccine patient had onset of shortness of breath, chest pain, and palpitations. He did not tell his parents so evaluation was delayed. Shortness of breath and chest pain self resolved. He presented ~2 months later with persistent palpitations and was found to have a new diagnosis of frequent ventricular ectopic beats. 2 months post vaccination his inflammatory markers and troponin were negative and his echocardiogram showed normal ventricular function. However, the clinical history suggests the possibility of post-vaccine myocarditis. I am not positive whether he received the Pfizer or Moderna vaccine but I believe it was Pfizer. I am also not 100% positive about the date of vaccination.
This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 01-NOV-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 22 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.
Missed second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        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 drugd provided. No treatment drugs provided. Patient was scheduled for second dose but missed it. It has now been 8 weeks and no second dose.
The patients mother stated he had a rash and hives all over his body and his eyes and hands were swollen. He was also vomiting. She gave him BENADRYL and called us for treatment.
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:  Immunization at 3:30. As he was driving home from work that evening, felt as if he had the flu
I broke out with Shingles.  Went to doctor immediately.  Gave me medicine and within a week, scabs were clearing up.  Still have marks but I feel they will go away in time
Diagnosed with sixth-nerve palsy in left eye. I have been receiving shots every 6 weeks or so in my left eye to reduce fluid, with no adverse affects over the past 12 months.
Arm was sore and painful to move for two days after the shot and this subsided however a red round mark at the injection site and a lump under the skin has remained for now 8 days. On days 6 forward, the site also became itchy and was hot to the touch. Redness is subsiding very slightly but itchiness and lump remain.
Right after shot swelling on tongue and throat.  Reason for hospital visit abdomen pain steadily increasing all labs were negative so if had to be a reaction to injection in addition to a lot of vertigo and nausea
Mild Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Mild Fever) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023, the patient experienced PYREXIA (Mild Fever). At the time of the report, PYREXIA (Mild Fever) outcome was unknown.        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.   Concomitant medications were not reported.  Treatment information was not reported.   Reporter did not allow further contact
Thursday 3/18: rash, large hive approx 3"x 2" and another smaller hive on upper right arm just below injections site. Site uncomfortable and itchy.
Her arm swollen; Arm red; Body aches; Chills; Fever of 102.5; Headache for 3 days; Dizzy; Incognitive; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), COGNITIVE DISORDER (Incognitive), ABDOMINAL DISCOMFORT (Upset stomach), PERIPHERAL SWELLING (Her arm swollen) and ERYTHEMA (Arm red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SPIRONOLACTONE and GABAPENTIN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (Dizzy), COGNITIVE DISORDER (Incognitive), ABDOMINAL DISCOMFORT (Upset stomach), ERYTHEMA (Arm red), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever of 102.5) and HEADACHE (Headache for 3 days). On an unknown date, the patient experienced PERIPHERAL SWELLING (Her arm swollen). At the time of the report, DIZZINESS (Dizzy), COGNITIVE DISORDER (Incognitive), ABDOMINAL DISCOMFORT (Upset stomach), PERIPHERAL SWELLING (Her arm swollen), ERYTHEMA (Arm red), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever of 102.5) and HEADACHE (Headache for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Varicella given on 7/26/12 L) arm - Pt. had swelling, redness, and pain the following day.
Case number PHEH2012US014957 is an initial spontaneous report received from a pharmacist on 26 Jul 2012: This report refers to an 18-year-old female patient. She was vaccinated with MENVEO (batch number: A10051) subcutaneously on 25 Jul 2012. No adverse event was reported following this medication error.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 02-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature of excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
This spontaneous report was received from an office manager and refers to a 9 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-OCT-2017, the patient inadvertently was vaccinated with a dose of VAQTA lot # M022531 with expiration date of 23-FEB-2018, for prophylaxis (strength, dose, route were frequency were not reported). No adverse effects were reported.
This report describes the occurrence of brachial plexus neuritis in a 4 month old male who received Infanrix. This report was received from the vaccinee's mother, who is a physical therapist. The vaccinee had no relevant medical history. Concurrent conditions and concurrent medications were not specified. Following previous vaccinations, the vaccinee experienced "just normal things, like swelling, slight fever, crying, lack of appetite (mild to moderate only)." On 3/26/02, the vaccinee received his second injection of Infanrix. On that date, he also received injections of inactivated poliomyelitis virus vaccine (IPOL), combination Haemophilus influenzae type B conjugate/hep B (Comvax), and Prevnar. Three hours post immunization, the vaccinee "was not using his left arm as much" and had a loss of appetite. The subject was seen by a physician, who reportedly made a diagnosis of brachial plexus neuritis. The mother reported that no treatment was given. The mother stated that the vaccinee had "80% of use (of left arm) within evening." The loss of appetite lasted "only for several days." The mother stated that the brachial plexus neuritis and loss of appetite had improved. The mother is a physical therapist and will be given her child therapy as soon as the physician approves. As of 4/16/02, the events were ongoing.
Throat swelling after Fluarix injection; Mouth swelling after Fluarix injection; This case was reported by a other health professional via sales rep and described the occurrence of throat swelling in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced throat swelling and swollen mouth. On an unknown date, the outcome of the throat swelling and swollen mouth were unknown.   It was unknown if the reporter considered the throat swelling and swollen mouth to be related to Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced both throat and mouth swelling after Fluarix injection.
On 8-9-2010 client was given H1N1 0.1ml. intradermally instead of TB-PPD in the left inner forearm. 8-10-2010 states had itching, redness at site. Took BENADRYL last eve. Now 8-11-2010 - 4cmx3cm red area, slightly warm to touch, itchy at site. Recommended cool pack - see HCP if concerns remain.