chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 6 year old grandson's cousin who on an unspecified date was vaccinated with a dose of MMR II (Lot# not reported).  The consumer stated that in the evening of the day the vaccine was given, her grandson's cousin "went in to convulsions" and was taken to the emergency department for evaluation.  Her grandson's cousin was diagnosed with a mild case of autism and on unspecified date, was receiving treatment for the autism.  At the time of the report the patient had not recovered.  Upon internal review, autism and autism were determined to be an other important medical event.  Additional information has been requested.
Initial report received on 15 January 2009 from a consumer. A 65-year-old patient, who had no concurrent illnesses, but who has allergy to tree pollen, plums, hazelnuts and Red Delicious apples, had received on 15 December 2008 a dose of FLUZONE SV 2008-2009 (lot number U2803AA). The route and site of administration was not provided. The patient had not received any other vaccinations within four weeks of 15 December 2008; and had not experienced any adverse events with prior vaccination including several flu vaccines. The patient was taking PRILOSEC at the time of vaccination on 15 December 2008; however the indication for this medication was not provided. Approximately one week after receiving the FLUZONE vaccine, the patient starting having eye and facial swelling with facial numbness and pain on the right side of his face. He also experienced headache. Per the patient, he subsequently developed a "shadow" in his peripheral vision which has continued to worsen. He stated he had lost 80% of vision of the right eye. The patient was evaluated by a health care professional and had numerous tests/procedures including a Magnetic Resonance Imaging (MRI) test and computed axial tomography (CAT) scan; however the results were not provided. the patient is to be evaluated by a neuro-ophthalmolosgist the week of 19 January 2009. It was not reported whether the patient had received any treatment at this time, or if any diagnostic laboratory data had been performed. At the time of this report, it was "unknown" whether the patient had recovered. Documents held by sender: None.  2/5/09 Received PCP, vaccine ophtho & neurooptho medical records of 12/15/08-1/27/2009.  Ophtho records reveal patient seen 1/2/09 for c/o floaters OD x 1 week which worsened over next 6 days with vision decrease OD.  Dx: vitreous detachment/floater OD & subsequent non-arteritic anterior ischemic optic neuropathy.   PCP records of 1/8/09-1/27/09 reveal patient in usual state of health except for vision decrease OD.  RTC 1/27 & dx w/anxiety disorder generalized.  Neuro-ophtho records of 1/22/09 FINAL DX: anterior ischemic optic neuropathy, right side; disk at risk, left eye; no evidence of corneal anesthesia either side; & history of low-normal BP.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 55-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.   It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
A physician reported that a 70 year old female received an initial injection of Pnu-Imune 23 on 01/09/01. That same day, the patient developed an injection site reaction characterized by 6 cm by 6 cm area of erythema and induration. She was treated with tapering doses of Prednisone "60, 40, 30, 20, 10 mg". The patient was also treated with diphenhydramine 25 mg every 4 hours for 4 or 5 doses.  The patient recovered.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Aug 27, 2021, single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. The patient developed malaise (didn't feel good the last time she had the 1st dose), with outcome of unknown. Additional information: Patient wanted to know if she can take the 2nd dose on Monday, Sep 20, 2021; she is scheduled Friday, Sep 17, 2021. She received the first dose Aug 27, 2021. She said she is attending a wedding event. She didn't feel good the last time she had the 1st dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
fever; chills; This is a spontaneous report from a contactable consumer (reported self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced fever and chills on an unspecified date. The outcome of the events was unknown. Reporter did not wish to be contacted for follow-up.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
8y/o healthy F presented in clinic on 8/21 with Suspected chicken pox in immunized child. Exposure to father with confirmed zoster. Afebrile with large crop of typical vesicles on trunk, limbs and labia. Moderately puritic, but afebrile. Isolation precautions: father to go to peds clinic and pick up two viral transport swabs: Ordered DFA and culture, as sensitivity of DFA not always 100%. Father was confirmed by viral culture. Note Pt was vaccinated wtih Varicella Vaccine 1st dose 12/7/2007 and MMR-Var on 5/2/11. Follow up: confirmed varicella infection (by DFA and PCR). First lesions: August 21 (Friday) 2015. Last new lesions Sunday 8/23/2015. Clinically significant case with 3 distinct crops of vesicles, now numbering more than 200 (close to 300) lesions Fever: low grade only, none higher than 100.4. Patient active, and other than pruritis and discomfort from lesions, no complications (no respiratory, neurologic). Exposure: father with documented zoster 10 days earlier. Risk factors: none identified, nl, healthy 8 year old. Immunization history:  Immunization History  Administered  Date(s) Administered  o DTaP (Diphtheria, Tetanus, acellular Pertussis) 04/18/2007, 02/11/2008  o DTaP-HBV-POL (Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio) 01/25/2007, 06/05/2007  o DTaP-POL (KINRIX) (Diphtheria, tetanus, acellular pertussis, polio) 05/02/2011  o HAV ped/adol 2 dose sch (Hepatitis A) 12/07/2007, 12/10/2008, 05/02/2011  o HBV (Hepatitis B) 12/02/2006  o HIB PRP-T (Haemophilus influenzae b) 01/25/2007, 04/18/2007, 06/05/2007, 01/07/2010  o INFan (Influenza attenuated virus, intranasal) 10/07/2010, 11/14/2011, 11/13/2012, 11/13/2013, 09/30/2014  o INFan H1N1-09 (Influenza H1N1-09 live attenuated, intranasal) 10/19/2009, 01/07/2010  o INFs pres free 6-35m (Influenza) 10/25/2007, 12/07/2007, 12/10/2008, 09/24/2009  o MMR (Measles, Mumps, Rubella) 12/07/2007  o MMR-VAR (Measles, Mumps, Rubella, Varicella) 05/02/2011  o PNUcn (Pneumococcal conjugate, pneumonia) 01/25/2007, 04/18/2007, 06/05/2007, 02/11/2008  o POL-IPV (Polio, Inactivated virus) 04/18/2007  o ROT5 (Rotavirus live, pentavalent) 01/25/2007, 04/18/2007, 06/05/2007  o VAR (Varicella, chickenpox) 12/07/2007
One day post vax lymph nodes were present and swollen behind left ear and above ear into hairline with blisters; pt experienced a slight fever and the affected areas were itching. Pt was treated with Benadryl.  Affected areas scabbed later.
Hives on L thigh, spread to R thigh, intermittent, comes and goes; rx Benadryl.
Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in left arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in left arm). At the time of the report, VACCINATION SITE PAIN (Soreness in left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Information has been received from a nurse practitioner, concerning a male baby, who on 01-SEP-2009, was exposed via uterus to a dose of GARDASIL (lot number 659054/0314Y). On the same day, the baby was also exposed to influenza virus vaccine (unspecified) and H1N1. On 21-APR-2010, the baby was born preterm at 36 weeks from mother's last menstrual period due to mother was bleeding. The baby was born healthy, with a weight of 6 lb 4.5 oz and apgar score of 8/9. Additional information is not expected.
Pt recv vax on 4/6/99; on 4/16/99 pt exp fever (104) x 48 hr, febrile seizure, generalized varicella form eruption x 72 hr-did not vesiculate fully
Information has been received from a licensed practical nurse concerning an 18 month old male with no pertinent medical history and no drug reactions/allergies who on 10/3/05 was vaccinated SC in the right arm with a 0.5mL dose of varicella virus vaccine live (lot # 649643/0421R). There was no illness at the time of vaccination. There was no concomitant medication. On 10/8/05 (also reported as 10/9/05), the patient's mother reported that she walked into the patient's room and thought he had a seizure. She indicated that she did not witness the seizure, but has experienced seizures in children, and the patient has appeared to have just had a seizure. The child felt hot to touch. She gave the child acetaminophen, and then noticed he had spots on his face, trunk, and legs. The mother called the physician on 10/10/05, and the child was seen on 10/11/05. The physician confirmed that the lesions were chickenpox. No treatment was ordered. No other information was available. There were no lab diagnostic studies performed. The physician indicated that the patient was stable. There was no product quality complaint. Follow up information received from a licensed practical nurse indicated that the patient recovered. There were no adverse events following prior vaccinations of the patient or siblings. Upon internal review, seizures was considered to be an other important medical event (OMIC). Additional information has been requested.
fine papular rash consistant w/viral or drug rash w/instructions to use DPh; MD wasnts info on chart that pt is allergic to flu vax;
This was my second dose.  The reaction began during the night after my 2:00 PM vaccination.  Bright red rectangular spot about 5 inches wide by 2 inches tall an inch below vaccination site.  Arm is swollen and tender to touch, and it Itches severely,   This also happened after my first dose but I mistakenly thought I?d been bit by a spider after the vaccination.  The first time, it took about five days to stop itching, and for the swelling to go down.
patient received 0.2ml of the diluted adult covid19 pfizer vaccine instead of the pediatric vaccine. patient didnt have any side effects from vaccination
bad muscle pain, severe headache, bad bone pains, neck pains,  exhaustion, runny nose, stuffy nose, sore irritated throat,  This has lasted now for 2 days.So far treated with Advil and benadryl.
Sunday following after a warm shower noted to right arm redness, warm, and pain making it difficult to raise arm
mom states child had fever, stop breathing, had convuls called 911 & taken to ER;no fever or sz activity # hosp;temp @ ER 101.2;WBC increased;
got shingles shot and then shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The reporter had heard of shingles had several flares very painful. The patient got the shingle shot and then got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
arm pain after previous doses; second dose >36 days after first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after first dose) and PAIN IN EXTREMITY (arm pain after previous doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (25 to 30 years ago). Concurrent medical conditions included High cholesterol, Allergy to chemicals (nitrates) and Allergy (MSG).   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain after previous doses). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after first dose) outcome was unknown and PAIN IN EXTREMITY (arm pain after previous doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had concomitant medications daily for high cholesterol and blood pressure. It was reported that patient was not immunocompromised. Patient neither diagnosed with COVID-19 nor tested positive. Treatment medications were not reported.   This case was linked to MOD-2022-559342, MOD-2022-559594, MOD-2022-559608 (Patient Link).
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 76-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 19-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical loation and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805513 was crossed linked to original cases 201804863 due to same reporter.
Urticarial lesion, > 10 measured 30-10mm currently resolving, using hydrocortisone for symptomatic treatment.
This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications  not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization; reaction: dizzy spells. The patient experienced asthenia (debilitated for a week), with outcome of unknown. Therapeutic measures were taken as a result of asthenia. Additional information: She stated she felt "horrible" after the 2nd dose and took Tylenol for her side effects. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101252699 (same patient and reporter, different dose and event).
This is a spontaneous report from a non-contactable nurse via a Pfizer sales representative. A male patient of unknown age received on an unknown date a single dose of TRUMENBA and HPV vaccine (manufacturer unknown), both for immunization. Medical history and concomitant medications were not reported. On the same date, in the evening, the patient had a severe headache, body ache and low grade fever. He tried to run in a school track meet and could not due to the way he was feeling. Outcome was not reported. No follow-up attempts are possible, information about batch number cannot be obtained.
entire face is red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (entire face is red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA (entire face is red). At the time of the report, ERYTHEMA (entire face is red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Progressive, persistent bilateral shoulder pain, bilateral UE, numbness / fatigue, diffuse headaches failing to improve with NSAID'S muscle relaxants, OT/PT.
Sore arm; Muscle soreness, like an ache "on and off" and then it went away; Had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group; Picking things up and dropping things; Having a tingling feeling off and on but that went away; Some weakness to her hand on the side of her injection; Feel discomfort at the injection site; Tired; Pain at injection site; This is a spontaneous report from a contactable consumer (patient's friend). A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Apr2021, from the time patient got the injection she started having a sore arm. On an unknown date in 2021, patient experienced muscle soreness, like an ache on and off and then it went away, had an ache or pressure when lifting her arm up that happened sporadically throughout the day in the same muscle group, she had 5,6,7 days where she was picking things up and dropping things and reports having a tingling feeling off and on but that went away. Consumer reported that 2 weeks ago the soreness started to come back, same place, same muscle, same ache. Patient was having some weakness to her hand on the side of her injection, Feel discomfort at the injection site, Tired and Pain at injection site. Patient reported that her friends also experienced similar symptoms. The event having a tingling feeling off and on was recovered on an unknown date in 2021. The outcome of rest all the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021684418 same patient/drug/similar event, different patient;US-PFIZER INC-2021687674 same patient/drug/similar event, different patient;US-PFIZER INC-2021687675 same patient/drug/similar event, different patient;US-PFIZER INC-2021687676 same patient/drug/similar event, different patient
Swollen Left Underam (This has reduced considerably, as of today) Redness of Skin at Injection site (This has vanished as of today) Itchy Rash in Injection site ( This has reduced considerably as of today) Muscle Pain & Headaches (THese have stopped as of today) Swelling & Pain at Injection site (These have gone as of today)
I had a swollen lymp node in my left armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient reported that first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot# EL9264), via unspecified route of administration on 04Feb2021 13:45 at single dose in the left arm for covid-19 immunization. Medical history included hypertension. Concomitant medications included Lycortin, Norvasc, Carvedilol, Aspirin, Doxycycline. The patient reported as, I had a swollen lymp node in my left armpit on 08Feb2021. Outcome of the event was not recovered.
Covid symptoms started 05/17/22; tested positive for Covid 05/22/22. It started with a scratchy throat and then laryngitis which isn't normal for me. I had nothing else for a good 4-5 days, but then I started with mild head congestion but no fever or cough. My doctor did prescribe me Paxlovid but I didn't take it because I ended up in the hospital twice before with medication reactions and I didn't want to have to deal with that. My symptoms weren't bad that I thought it was necessary to take the medications. As of Friday or Saturday I felt perfectly fine and feel like myself. I've been able to walk 4-5 miles when I had it.