chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in tongue; Minor internal throat swelling; Severe dry mouth; Swollen glands in throat; Tingling in hands; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 12:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and known allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 13:15, the patient experienced tingling in hands, tingling in tongue, severe dry mouth, swollen glands in throat and minor internal throat swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in hands, tingling in tongue, severe dry mouth, swollen glands in throat and minor internal throat swelling were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-AUG-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
pt recvd vax; pt had swelling & redness; vein also swollen in RL; there was redness @ site of vax; instructed to put cool compress & warm compress;
the office had already given vaccine to the patient from this shipment before they realized that the vaccines were not viable, no adverse event; received the shipment of Fluzone QID late with no AE; 7 years old patient received Fluzone QID in left thigh / no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case linked to 2019SA295194, 2019SA295209, 2019SA295207 and 2019SA290919.  This case involves a 7 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6686LA, expiry date: 30-Jun-2020), via intramuscular route in the left thigh, on 17-Oct-2019.  Relevant medical history and concomitant were unknown.   It was an actual medication error due to incorrect product storage and vaccine administered at inappropriate site.  It was a case of product shipment delay.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
Felt like she had no breath; couldn't walk; felt paralyzed; the pain moved from the arm to her back; Pain in left arm; This is a spontaneous report from a contactable consumer.   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     There were no concomitant medications.  The patient experienced the pain moved from the arm to her back (back pain) (non-serious) on 31Jul2021 with outcome of not recovered , couldn't walk (gait disturbance) (non-serious) on 04Aug2021 12:00 with outcome of not recovered , felt paralyzed (paralysis) (non-serious) on 04Aug2021 with outcome of recovered , pain in left arm (pain in extremity) (non-serious) on 29Jul2021 16:00 with outcome of unknown , felt like she had no breath (dyspnoea) (non-serious) on 04Aug2021 12:30 with outcome of recovered.  The patient underwent lab tests and procedures which included x-ray: unknown results   on 2021  .  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of the pain moved from the arm to her back (back pain), felt like she had no breath (dyspnoea).
Information has been received from a family nurse practitioner concerning a 56 year old female with no allergies and with a history of pneumonia "earlier in the he year" who on 24OCT2003 at 10:30 Am was vaccinated IM in the right deltoid with a first 0.5 dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. On 29OCT2003 the pt developed a cellulitis noted to be an abscess at the injection site.  On 29OCT2003, the pt had  a fever of 102 degrees Fahrenheit for one day. On 31OCT2003, the pt was note to have erythema and induration of the upper arm with tenderness and a firmness of tissue. The pt was prescribed Augmentin 875 mg PO BID for 10 days. Unspecified medical attention was ought. There was no product quality complaint involved. There was no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the pt or her siblings The reporter also indicated that one other pt was developed a cellulitis. This is a consolidation of two reports concerning the same pt. No further information is expected.
I did not feel good 12/02/22, by 12/07/22 and 12/08/22 I was feeling even worse. I used two at home COVID-19 test from on 12/16/22 that came back negative. Work requested that I take another on 12/17/22 that also came back negative. I went to a clinic and saw the saw doctor that I had seen back in September when I had tested positive for COVID-19. He felt that I may have a cough variant of asthma and I needed to be using my albuterol inhaler more. I cough so hard that I have been throwing up. I started taking OZEMPIC. The coughing seems to come on at night, in the cold air. I have been taking TUMS to help keep my stomach calm, so I do not want to throw up. I will be following up with the doctor in January.
itchy red bumps/rash which spread from one bump to 4 inches and is also warm to the touch.  Showed up one week after vaccine and is rapidly spreading.
Large area of erythema 4/5" long by 4" wide on left upper thigh.
flu-like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The report was via chat  The reporter was a family nurse practitioner student. The patient experienced flu like symptoms after receiving Shingrix. The reporter did not have the batch number and expiry date or the exact date of vaccination. The report was via chat and the reporter did not elaborate on what exact flu like symptoms were experienced by the patient.
had an allergic reaction to the first shot; second shot scheduled date changed; Hives; Had hard time Breathing; Face turn red; Big Blotches; Temperature spiked really bad; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On an unspecified date in 2021, after first dose of vaccination, patient had an allergic reaction. Patient broke out hives in the waiting zone and then had a hard time breathing and face turn red and had really big blotches and temperature spiked really bad [onset date: unspecified date in 2021]. Patient asked to confirm that if had an allergic reaction then is the regulatory authority recommending not to get the second shot? Reportedly, second shot scheduled date changed. It was originally scheduled on the 3rd but patient had an allergic reaction, so had to change the date to go with somebody else, so that they could actually drive patient there. Patient have already done that. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
vaccine was reconstituted with sterile water instead of normal saline and administered.  Patient is not reporting any adverse effects at this time.
Immunization on 4/15/03. Developed rash 2 weeks later, continued to worsen. Now resolving but still present on legs faintly.
Mom reports pt had 2 seizures, 1 each day for 2 days, approx 2 wks following MMR/HIB; seizures were not associated w/fever;
arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th August 2022, the patient received Shingles vaccine. On 17th August 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm. On 17th August 2022, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the shot day before reporting.  The patient reported that the needle was bad and of course her arm was sore the next day of vaccination but the patient was fine.  It was well worth it.  A couple of years ago the patient saw some one who developed shingles and she remembered he was in agony for a couple of weeks.  That was why the patient took the shot and it would be worth it. Additional supportive information: The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR121378 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR121378:Same reporter
woke up with dozens upon dozens of red bumps all over my back; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 05May2021 the patient reported that after a weeks of her first shot and the other day she woke up with dozens upon dozens of red bumps all over her back, she told that it was not normal acne, and not a diet change as well, which was highly unusual for her and she felt horribly self conscious and uncomfortable, since this was her reaction after the first dose, she was not sure what the "crueler dose #2 would do" to her body. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event woke up with dozens upon dozens of red bumps all over back was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
4 year old boy with complicated medical condition-autism, seizure disorder, microcephaly - received 4 year old vaccines at regular check up. Was in good health at the visit. Following day, had a fever, then began having seizures -> status epilepticus later admitted to hospital where he went into hypotensive shock and multi organ failure. Currently in critical condition.
5 min after vaccine: nerve pain in upper right arm traveled in a line into right side of neck, up to just below the ear. Pain traveled directly from site of vaccine in arm and up through neck.  10 min after vaccine: Nerve pain down began in a line down right arm and into pinky and ring fingers of right hand. 20 min after vaccine: Tongue tingly (entire right side only, left side normal), pain in jaw, headache beginning in right temple. OTC Tylenol and then Ibuprofen taken 1 hour, 15 min after vaccine helped dull headache but not other symptoms. Nerve pain was intermittent until bedtime. The next morning, woke to right eye crusty from tearing, right eye tearing at corner (clear, like tears), consistently drippy right nostril (clear), loss of taste in tingly right side of tongue (could taste on left side of tongue), tingly right side of lips, slight drool right side mouth, outside of ear slight tingly. Headache returned, only in right temple extending to above right eye. Right side of face felt heavier than left side. Sensitivity to light, sound. Took Tylenol and Ibuprofen. Over 9 hour period (24-28 hours after vaccine given), most symptoms resolved, including taste. The next day (48 hours after shot), symptoms remaining are right eye has very slight tearing, right side of face feels a little "heavier" than left side, but drastically different from day before. I have NEVER had anything like this happen before after a vaccine or otherwise.
This spontaneous report as received from a registered nurse who read a life story of a patient of unknown age on a website. On an unknown date the patient was vaccinated with GARDASIL (dose, lot no and route not reported). On an unknown date the patient experienced depression after vaccination. The outcome of depression was unknown. This is one of several reports received from the same source. Additional information is not expected.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years, experienced other anaphylactic shock, NEC (confirmed) (since 21-Dec-2012, resolved on 21-Dec-2012), severity and seriousness were not assessed, while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 20-Dec-2011. The patient was seen as outpatient visit treatment medications included: ibuprofen (600mg, TID, oral) started on 21-Dec-2012, stopped on 20-Jan-2012 (indication unknown); methylprednisone (62.5mg/mL, once, injection) started on 21-Dec-2012, stopped on 20-Jan-2012 (indication unknown). The patient also received RECOMBIVAX-HB on 20-Dec-2011 (lot#AHABB223DA, manufacture SKB); meningococcal (MCV4P) on 20-Dec-2011 (lot#U4052AD manufacture PCM), tetanus-diphtheria-pertussis (Tdap) on 20-Dec-2011 (lot#AC52B075AA manufacture SKB), and influenza on 20-Dec-2011 (lot#04949221A, manufacture CSL). At the time of the report the outcome of the AEs were: Other anaphylactic shock, NEC: recovered/resolved. Adverse events within 42 days of vaccination: headache F/U started on 22-Dec-2012, stopped on 22-Dec-2011, the patient was seen in outpatient visit, outcome, severity and seriousness were not assessed; headache F/U started on 23-Dec-2012, stopped on 23-Dec-2011, outcome, severity and seriousness were not assessed. The medical history of the patient was not specified. Concomitant medications within 42 days of vaccination: promethazine (25mg, Q6H, oral) started on 23-Dec-2012, stopped on 26-Dec-2012 (indication unknown); azithromycin (250mg, oral) started on 29-Dec-2012, stopped on 03-Jan-2012 (frequency and indication unknown); ibuprofen (800mg, TID, oral) started on 29-Dec-2012, stopped on 05-Jan-2012 (indication unknown). The patient's past medication were unspecified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. Action taken with suspect drugs: Adenovirus vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus vaccine.
Inappropriate route of vaccination; Painful arm lasting more then a week; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received Shingrix (subcutaneous). On 5th October 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In October 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Pharmacist called and reported that she administered the Shingrix on right arm. She recalls that she gave it intramuscular but the patient claimed that they received the vaccine subcutaneously.She stated that she did not know if she did inadvertently give it subcutaneously, which led to intramuscular formulation administered by other route. The patient had painful arm lasting more than a week. The pharmacist would be following up with the patients. She also stated that GlaxoSmithKline can contact her if there are any additional questions. This case linked with US2019AMR190695, reported by same reporter.
Near constant headaches of varying intensity  (started after the vaccination and still continuing ~4 weeks later)
upper body aches, fever, chills, fatique, one small rash on upper body, sinus pain, headache
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided No treatment received by the patient
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-OCT-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 64 hours with 48 C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 C, 264 hours with 33 C, 8 hours with 30 C as the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Pain in arm; muscle pain; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and MYALGIA (muscle pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced PAIN IN EXTREMITY (Pain in arm) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and MYALGIA (muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Event occurred due to first dose vaccine administration.  No concomitant product information was reported.  No treatment information was reported.   Action taken with mRNA-1273 in response to events was not applicable.
Left upper arm swollen, red, warm tender, patient febrile feels achey and generally poor.
Information has been received from a pharmacist referring to a 62 year old female patient with allergy to codeine and related (unspecified). No other information of medical history was reported. On 09-FEB-2015, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX lot # K015308, expiry date: 17-DEC-2015, subcutaneously. Concomitant therapies included hydrochlorothiazide, ZESTORETIC, FLONASE, ZETIA, estradiol (manufacturer unknown), duloxetine hydrochloride and omeprazole. On 20-FEB-2015 (reported a 20-FEB-2015 to 21-FEB-2015), the patient experienced itching and a rash at the waist area. On unknown dates, the patient called and saw the pharmacist and then went to an urgent care and saw a physician. The patient was given prednisone (manufacturer unknown) and ATARAX for treatment. The outcome of adverse events was unknown. Additional information has been requested.
light tiredness; tiredness in the legs only after his second dose; heaviness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (light tiredness), FATIGUE (tiredness in the legs only after his second dose) and LIMB DISCOMFORT (heaviness in the legs) in a male patient of an unknown age who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) .5 dosage form. On an unknown date, the patient experienced FATIGUE (light tiredness), FATIGUE (tiredness in the legs only after his second dose) and LIMB DISCOMFORT (heaviness in the legs). At the time of the report, FATIGUE (light tiredness), FATIGUE (tiredness in the legs only after his second dose) and LIMB DISCOMFORT (heaviness in the legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-064063.