chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of lip and cheek angioedema  11/15/19   Recurrent cases to follow with swelling of submandibular salivary glands and lymph nodes  Eventual signs leading to diagnosis of Chrone?s Disease.  I am unsure of relativity but after doing much reading  Especially about GBS  and possible gastrointestinal issues, I feel I would be remiss not to report  even if after all this time.
pt reporting feeling rash/flush sensation at face only after IM injection of Moderna, pt was immediately evaluated- v/s, p/e, without visual skin changes at face stable no difficulty breathing or swallowing; pt was given 12.5mg PO benadryl and observed for 30 minutes; pt reported complete resolution of symptoms at 30 minutes; pt wanted to go home; return precautions given; recommending 2nd vaccine at hospital
Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle; This spontaneous case was reported by a patient and describes the occurrence of SKIN HAEMORRHAGE (Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AL21A, 088D2119, 1773 and 11320A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN HAEMORRHAGE (Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle). The patient was treated with DENOSUMAB (PROLIA) for Skin disorder, at an unspecified dose and frequency and PARAFFIN (VASELINE [PARAFFIN]) for Skin disorder, at an unspecified dose and frequency. At the time of the report, SKIN HAEMORRHAGE (Bleeding under the skin/unsightly bruising or bleeding/she started getting what looks like bleedskin. Its on both of her shins down to her ankle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was reported that the small round areas were diagnosed as bleeding under the skin by the dermatologist. It started off as little tiny bumps. Then the bumps became bigger and more profound. From March, patient had both of the shins with 4 inch area from knee to ankle with unsightly bruising or bleeding. It was further cleared by the reporter that there was no trauma, pain, itching or swelling to that area just bruising under the skin. The COVID shot was the only medication that had changed with the patient's regular medication.  Patient went to the dermatologist and internal medicine doctor who ordered for a complete autoimmune blood work-up, and results will take 5 weeks to complete.  Patient also reported that she was unable to go to the community pool due to the reported event. The patient had iced the area and tried homeopathic therapies. Also used Arnica, some lotion  and tea tree oil.   This case was linked to MOD-2022-644598, MOD-2022-644257 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Additional follow-up received, suspect drug information and I-narrative was updated.
84 year old male presented to hospital complaining of weakness after the flu shot given 9/14/23 (manufacturer: Seqirus, LOT#: 371600). He described it as progressive, starting at his toes, and moved upwards, till his groin, he was not able to sit or stand and reported bilateral lower extremity swelling and pain. He also reported urinary retention and constipation. Findings: MRI lumbar spine without contrast (solitary kidney, CKD IIIb) revealed multilevel degenerative changes with severe central canal stenosis at L3/4 and L4/5 with mild stenosis at L1/2. Unremarkable appearance of terminal cord and cauda equina. EMG/NCV test shows compatible, though not conclusive, of GBS LP: elevated Glucose 123, elevated Protein 63. Per neurology, diagnostic tests and patient presentation highly suggestive of Guillain-Barre syndrome and plasmapheresis was initiated for 5 rounds every other day. Patient has currently completed plasmapheresis session 3 of 5 and reports feeling stronger. Of note, patient reports similar weakness after receiving a COVID vaccination in the past but that the symptoms improved with time.
Information was received from a consumer via a medical inquiry on 14SEP2018. A 22 year old female experienced sore throat, stuffy nose, drainage, vomiting, diarrhea and nausea following immunization with smallpox vaccine. Medical history: 'bad hip' but otherwise healthy. On 11SEP2018 the consumer received immunization with smallpox vaccine in the left arm (lot number unknown). The following day, she developed a 'really bad sore throat, stuffy nose and a lot of drainage. On 13SEP2018, while in the field, she developed nausea with vomiting and diarrhea. She reported concern related to returning to the field the following day due to the severity of her symptoms. On 01OCT2018, follow up with the consumer revealed that she was treated with an unspecified nausea medication; all symptoms resolved within a week. No further information is expected.
Indurated erythematous injection site. Symptoms started 2 days after injection & progressively worsening. (-) f/c/s. (-) SOB (-) angioedema. Indurated area 6.5 x 7.5 cm.
Information has been received from a registered nurse concerning a female patient who was vaccinated with a dose of GARDASIL. It was reported that the patient fainted after getting GARDASIL. The patient sought unspecified medical attention. The patient's final outcome was not reported. Additional information has been requested.
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
I got sick with every single shot (Pfizer COVID-19 Vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder" (unspecified if ongoing), notes: Synthroid is what I take for my thyroid. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Bnt162b2 (Dose: 01, single, I got sick with every single shot (Pfizer COVID-19 Vaccine)), for COVID-19 Immunization, reaction(s): "I got sick with every single shot (Pfizer COVID-19 Vaccine)". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got sick with every single shot (Pfizer COVID-19 Vaccine)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported patient had the first two dose during Covid then had the booster then just had the last booster that was offered the one that just came out and patient got sick with every single shot (Pfizer COVID-19 Vaccine). Patient took some vitamins.   The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112514 same patient/drug, different dose;
pt recvd vax 3NOV95 & 8DEC95 called clinic & reported lt arm & shoulder have been sore ever since receiving flu shot exactly 5 wks to the day 3NOV95;pt cannot lift 5yr old child nor can raise lt arm above head;pain in upper arm & shoulder
Vaccine leaked out of patients arm; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Vaccine leaked out of patients arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Vaccine leaked out of patients arm). On 23-Apr-2021, INCORRECT DOSE ADMINISTERED (Vaccine leaked out of patients arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  No treatment medication were reported.
Approximately 1 hour after his vaccine, the mother states the patient developed a fine rash, not hives, all over his body trunk, and extremities. He had a low grade fever, and vomited for several hours. She did not seek medical attention, and states he was not dehydrated. Reported 2 days after receiving vaccine 3-29-01 and states all symptoms were gone the next day except the rash, and it has faded.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, frequency and route of administration were not provided), lot # K007263, expiration date 09-JUN-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
pt recv vax & 3 days later had soreness & mild swelling @ inj site;no heat;also vomited x 1;some mild facial swelling;No SOB, no wheeze;reports low grade fever;tx w/DPH;
arm itching; arm swollen; lump near left neck; injection site sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL9267, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 21Feb2021 18:39 as DOSE 1, SINGLE for covid-19 immunization (68 year when vaccinated). Medical history included ongoing hypertension and ongoing bone disorder. Concomitant medications included alendronate sodium (ALENDRONATE) taken for an unspecified indication, from an unknown start date, lisinopril (LISINOPRIL) taken for an unspecified indication, from an unknown start date. The patient previously took bactrim, flagyl 250, flu vaccine and experienced pyrexia. On 28Feb2021, the patient developed arm itching, arm swollen, lump near left neck and injection site sore. The patient was not taken to hospital or to any physician for the treatment. The patient rubbed alcohol for the treatment of the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Health Department called stating that this patient went in for a plasma donation and they noticed her Hep B levels were off
Patient called and complained of arm redness and difficulty breathing. RPh on duty told patient to go to ER immediately. Patient was given Benadryl and sent home.
Actual injection was painful. Nine days later still very sore. Unable to move arm first thing in morning because of soreness.
diarrhea after she eats food; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea after she eats food) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]) and ANASTROZOLE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (diarrhea after she eats food). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea after she eats food) outcome was unknown. Not Provided          Patient experienced diarrhea after she eats food, she did not have a particular date but stated after she received the 1st dose and has continued even after she received her 2nd dose for which she has taken Imodium. Action taken with RNA-1273 in response to the events were not applicable.
Rash under injection site, came in to have site looked at by Dr. Pt is ok.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-DEC-2015, the patient was vaccinated with improperly stored doses of ROTATEQ (orally, lot # L025598, expiration date 13-JAN-2017; dose was not reported) and PEDVAXHIB (lot # L030865, expiration date 07-JUN-2018; dose and route of administration were not reported). NO adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
while I had the shot in the left arm, I've had tingling; some numbness in right arm and hand; some numbness in left leg; This is a spontaneous report from a contactable other hcp (patient). A 68-years-old female non pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199 and Expiration Date not reported) via an unspecified route of administration, in Arm Left on 05Mar2021 11:30 as 1st dose single dose for COVID-19 immunization. The medical history included known allergies of Cipro, chocolate, latex. The concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL) and vitamins. The patient did not have COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient reported on 05Mar2021 01:00 PM, while she had the shot in the left arm, she had tingling and some numbness in right arm and hand and left leg. The patient reported, it Still continued and now intermittently almost 24 hours later it was less severe than when it started 90 minutes after injection. The patient did not received treatment for the events. The outcome of events was resolving.    No follow-up attempts are needed. No further information is expected.
Cold; Small headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and HEADACHE (Small headache) 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 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 NASOPHARYNGITIS (Cold) and HEADACHE (Small headache). At the time of the report, NASOPHARYNGITIS (Cold) and HEADACHE (Small headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
pt recv hep A 6/16/99 pt accidentally given hep A #2 7/28/99;had been to MD few days a/7/28 because fatigue;mono & strep negative;7/29/99 devel swelling in lymph nodes on rt side of neck, rt side ribs sore, lethargy, sleeping 4hr during day
No addittional adverse experiences reported as a result ofthe vaccine administration; Office manager responsible for vaccines calling to report administration of expired doses of RECOMBIVAX; This spontaneous report has been received from an office manager, regarding a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies was not provided.  On 09-NOV-2021, the patient was vaccinated with am expired single dose of hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB) as prophylaxis (lot number S022584 valid, and expiration date reported and validated as 31-OCT-2021) (exact dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (expired product administered); no temperature excursions, no additional adverse experiences reported as a result of the vaccine administration (no adverse event).   This is one from several reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA004039:
5 hours after immunization began having abdominal pain. Developed diarrhea during the night and lasting 24 hours. One third day had nausea, vomiting, headache, exhaustion.  Continues to have some abdominal discomfort.  Home COVID test - result negative. Although she reported this as a reaction to immunization, she is now wondering if she had a viral illness.
Close to 1100 she began to complain of not feeling well, primarily complained of feeling dizzy, feeling a little weird but felt it would pass. Around 1115 she was still dizzy, stated she didn?t have much to drink or eat, so we brought her water and a snack.  No hx of diabetes. 1120 she looked flushed, and now had tingling in her left arm.  Took her BP 140/70, HR 70,  temp on her forehead 97.1.   1130 she continued to have a strange feeling in her arm from her shot site to her left hand, and up her neck.  Vaccinator counseled her to take an antihistamine once she gets home. Patient called her husband and her son who would take 40 minutes to come get her. She began to exercise her left arm, and began to feel better. She left with her family at approximately 1:00, still a little dizzy, no longer flushed with less discomfort.  We called her at 7;15 pm and she reported that symptoms had resolved.  Took Zyrtec. Extended observation and sent home.
Initial report received from consumer on 13 OCTOBER 2014. A female patient (age was not reported), whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA (batch number, expiry date, route, site of vaccination and dose number was not reported) in the past year that contained some kind of aspirin product on an unspecified date. The patient had experienced swelling of her whole arm with heat and pain on an unspecified date. The patient required emergency room or doctor visit. The lab investigation and corrective treatments were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were not reported. At the time of this report, the outcome of the event was resolved no an unspecified date. List of documents held by sender: none. Follow up information was received on 05 JANUARY 2015: No  new  information was reported.
soreness at injection site; had a big knot on his arm; indigestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: Unknown) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: has had for a while; "kidney disease", start date: 2020 (ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "soreness at injection site"; LIMB MASS (non-serious) with onset 2021, outcome "recovered" (2021), described as "had a big knot on his arm"; DYSPEPSIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "indigestion".  Additional information: Patient received the first dose about three weeks ago (at the time of report) in his left arm and experienced soreness at injection site, had a big knot on his arm and indigestion. These events have resolved. Patient works from home. He tried to work but laid back down. He feels a little better after sleeping. No previous immunization with the Pfizer vaccine considered as suspect. No Other Products and Relevant Tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt noted voliently sneezing for 30 minutes, feeling all hsitamines increasing
Body ache; Warm Head; This is a spontaneous report received from a contactable consumer, the patient. A 63-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 17Mar2021 at 12:00 PM (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes and liver cancer. Concomitant medications included ozempic (MANUFACTURER UNKNOWN), jardiance pravastatin (MANUFACTURER UNKNOWN) and turmeric (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 23Feb2021 at 14:00 PM (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had no symptoms associated with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not have any allergies to medications, food, or other products. On 17Mar2021, patient experienced warm head and body ache. The patient did not receive any treatment for the adverse events. The clinical outcome of the events warm head and body ache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I tested positive for COVID-19 on 11/28/22. I had a runny nose, cough, and brief sweating, and light chills. I had no fever though. I was prescribed 5 days' worth of PAXLOVID. I wasn't feeling terrible to begin with, but I started feeling better after taking PAXLOVID. I tested negative on 12/6/22.