chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 12-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014106: US-009507513-1905USA014099: US-009507513-1905USA008566: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
became ill w/inc congestion & h/a 1 wk p/inject ? related flu vax;
On 1/15/13 gave vaccines at around 1335. At 1730 he took nutritional supplement and around 1830 felt itching in armpit. Took restoril at 1930 and woke up to more itching at 1400 on 1/16/13. Referred to allergy clinic. Temp exempt from anthrax/yellow fever vax. Member denies taking oral typhoid.
Arm very sore, injection spot is swollen 2 in x 1.5 in. Red and warm to touch. I have been feeling nauseous and have had the diarrhea and stomach ache.
pt recv vax & stated that pt devel the flu w/cough, sore throat, & sore muscles;
Patient received her second dose of shingrix and later developed severe joint pain across many joints.  The pain was severe enough that she was unable to walk.  She went to the ER for evaluation where she was given pain meds and discharged.  The pain continued and she went back to the ER the next day where she was treated again. 3 days after the injection, patient reports joint pain is subsiding and she is now able to walk again.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. The nurse practitioner informed that on 28-AUG-2014 the patient was vaccinated with PROQUAD injection, 0.5 ml, subcutaneous, which expired on 22-AUG-2014 (lot number were not reported). No adverse effects were reported. The outcome of the event was unknown.   Follow up information received with updates on 28-OCT-2014, regarding 5 year old female patient with known demographics. It was reported that on 25-AUG-2014 at 3:00 PM, the patient was vaccinated with second dose of PROQUAD injection, lot # J002306, expire date 22-AUG-2014 to the left arm.  No adverse effects were reported. This is one of the several report received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 9 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 06-JUN-2018, the patient was inadvertently vaccinated with VAQTA dose and route of administration were not provided (lot # N030287 and expiration date 22-JAN-2019) for prophylaxis. No adverse effects reported.
fever / Fever was 101; fatigue; muscle aches; chills; neck hurts; mild asthma attack /  Her peak flow number was low; nausea; chest tightness; headache presented; fist dose in May or June of 2019 / second dose 11/17/2020; was dizzy; blood pressure dropped; feeling wired; coughing; could not sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bronchitis. Previously administered products included Shingrix with an associated reaction of nausea (received 1st dose in May or June 2019, refer case US2020AMR230099) and Advair (on an unknown date received Advair).   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced insomnia and cough. On 17th November 2020, the patient experienced headache, blood pressure decreased, weird feeling, dizziness and drug dose administration interval too long. On 18th November 2020, the patient experienced chills, fever, fatigue, muscle pain, neck pain, asthmatic attack, nausea and chest tightness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, chills, fever, fatigue, muscle pain, weird feeling, neck pain and asthmatic attack were recovering/resolving and the outcome of the blood pressure decreased was recovered/resolved and the outcome of the dizziness, nausea, insomnia, chest tightness, cough and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache, chills, blood pressure decreased, fever, fatigue, muscle pain, weird feeling, neck pain, asthmatic attack, dizziness, nausea, insomnia, chest tightness and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and 10 minutes after was dizzy and her blood pressure dropped and 30 minutes later the headache presented.  Fever, chills, muscle aches nausea and fatigue presented and could not sleep and reported feeling wired. The patient neck hurts and had a mild asthma attack described as chest tightness and coughing and peak flow number was low and she did a breathing treatment and was better. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230099:same reporter
Pt was sitting on exam table after vaccine and she felt dizzy.  She was assisted to lying position on table by mother.  A few seconds later nurse arrived in room and pt had rigid posture.  Her face was red, then blue, and patient had ragged breathing.  Her third and fourth fingers of her right hand were clenched, and her right arm was contracted.  Pt's eyes fully dilated.  Another nurse elevated pt's legs.  A few seconds later Pt stopped breathing for about 5 seconds and nurses performed vigorous sternal rub, causing patient to resume ragged breathing.  A few seconds later, Pt heaved, but did not vomit, was then turned to her left side.  A few seconds later, pt started kicking for a few seconds, then relaxed, and was immediately responsive.  Pt stated her name when asked, and was breathing calmly and normally.  No loss of bladder or bowel function.  Total non-responsive time was about 45 seconds.  Pt was then kept supine for 5-10 minutes, then sitting for 5 minutes, then standing.  No further loss of consciousness.  Multiple sets of BP and pulse, and O2 sats obtained immediately after episode.
Nausea, chills, fever peaking at 102 degrees at 12:30 AM 10/22/2014 slowly decreasing to 96.9 degrees at 9:00 AM 10/22/2014.
BODY PAINING/BODY ACHE; FEELING VERY COLD; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a 23 year old female. 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: Unk) dose was not reported, administered on 26-AUG-2021 11:00 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 26-AUG-2021, the patient experienced feeling very cold. On 26-AUG-2021, the patient experienced body paining/body ache. On 26-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feeling very cold, and body paining/body ache. This report was non-serious.
My son received his flu shot (no other vaccinations done at this time) around 10:40 in our Pediatricians office during flu shot clinic.  About 10 minutes after receiving his shot we were in the elevator and heard a thump behind us.  I turned around and my son was having a grand mal seizure on the floor of the elevator.  He was stiff, shaking and eyes were open and rolled back in his head.  I am a nurse (BSN) and I have training in recognizing a seizure.  It lasted about 30-45 seconds before he started to come to.  He doesn't remember what happened and was confused for a short time afterwards.  My husband picked him up and ran back upstairs to the Peds office where he was diaphoretic but didn't feel overly warm tp the touch.  I asked them to check a Blood Sugar which was reported to be 100.  His Blood Pressure remained low for a while afterwards and was dizzy when sitting up.  They monitored his BP for about 30 minutes afterwards until it returned to his norm and was able to sit without feeling that he needed to lay back down.  He was sleepy the reminder of the afternoon and by evening he felt himself again.  He was 100% healthy prior to getting flu shot, has received flu shots in prior seasons without reaction.  He has never had a reaction to any vaccine he has received and is up to date on all vaccines.  He has never had a seizure prior to receiving this flu shot.
Patient presents to hospital with rapid irregular heart beat, shortness of breath, chest pain. Patient diagnosed with new A Fib. PCP office 2 weeks prior reports no rapid irregular heart beat or cardiac abnormalities for patient.
Dry hacking Cough began within 6 hrs of vaccine, becoming productive within 5 days, mucous continuing from clear to yellow/ green to thick tan on Nov 3, ARNP appt 11/8 = sinus infection, started Augmentin bid x 2 daily, Flonase, Albuterol, Benzonatate.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time for the first time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 144 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
I developed a high heart rate an hour after the vaccine. Normal resting HR is 64; HR fluctuated bw 80-173 since shot.  Has persisted since shot (now 30 hours past). Went to ER, had EKG, chest X-ray.
POTS, brain fog, numbness in legs feet and hands, bad head ache, every time she eats she feels nauseous, she stays tired. Has no energy and that's not patient she has always been very out going and athletic she has cheered and played softball all her life until she got the vaccine and wasn't able to play do to being sick and being put on home bound due to POTS.
Arm soreness, in my upper arm muscle, that was expected at first but continues to now.
Mom had chest pain radiating to back and high blood pressure within 1 hour of shot. Does not have regular episodes of angina. Admitted to Hospital to rule out cardiac issues. Liver enzymes also elevated.
patient given oral typhoid vaccine. had red bumps all over legs, mild abdominal pain.  her primary care dr gave her Cipro and told her to stop taking the rest of the vaccine [series of 4 pills - she had taken 2]
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 47-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. The patient's past medical history included immunocompromised (had an unknown immunosuppressive disorder). On 4th December 2018, the patient received the 2nd dose of SHINGRIX. On 4th December 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. In March 2019, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that approximately 3 months later the patient was complaining of an Injection site reaction, possibly a rash at injection site. The SHINGRIX was indicated for age of 50 years and above however, the patient of age 47 years received it, which led to inappropriate age at vaccine administration.
Heaviness in his chest; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 66-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration in left deltoid as 2nd dose, single dose on 10Apr2021 at 15:30 (Lot number- ER8730) and as 1st dose, single dose (Lot number: EL 3302) on 19Mar2021 at 15:30 for COVID-19 immunization at pharmacy/drug store. Medical history was not reported. Concomitant medication included calcium, ergocalciferol (VIT D). Patient did not receive any other vaccination within four weeks prior to the first administration date of the suspect vaccine. Patient stated with the 1st vaccine he had heaviness in his chest and that went away and when he had his 2nd vaccine it came back it. It was reported that with the 1st vaccine the heaviness in his chest started 1-2 days after and he thinks it started to ease up a few days before he got the 2nd vaccine but it did not go totally away and he would like to report it. Patient stated with the 2nd vaccine the heaviness in his chest started 1-2 days later and improved and is now totally gone. Patient does not recall when it stopped, it gradually went away. Not required to visit emergency room and physician office. The patient was taking Covid 19 vaccine because of his age and people telling him he should get it. The outcome of the event was recovered.   Information on Lot/Batch number is available; Further information has been requested.
Vertigo-viral ear infection resulting in hearing loss, vision and eyesight changes, severe imbalance and abnormal gait. General sick feeling. Consulted 16 different doctors prescribed therapy twice. Persistent headache.
Patient reports that with her 2 previous vaccines, she had a reaction of tingling in throat and tongue (felt like she was injected with lidocaine). Also stated that her Blood Pressure dropped at that time and she felt better after an hour. Booster dose of Pfizer given in EMS room at 3:51 PM after patient had received 25 mg of Benadryl PO @3:45 PM.  @3:54 PM, patients complains of tingling in back of throat and tongue and feeling a little dizzy. Second individual called and came to EMS room for support. Patient refuses cot. After 30 mins, patient states she only has a little tingling in front half of tongue. States she feels like she can go home. Patient is with her parents and will go home with them, she states. Patient is drinking fluids well without difficulty. Left at 4:26 PM. Second individual accompanied her to the exit and to her car. Tingling was significantly less and patient wanted to leave.
cough, chills which escalated rapidly to full blown flu-i.e. fever, painful aching joints & URI;
Pt states, after being notified of ad on TV, that she has had the symptoms hot flashes, malaise and increased sweating under arms since first shot of GARDASIL given 9-27-07.  Second shot 11-29-07, 3rd shot 4-29-08.  No symptoms or reactions told to nurse at any visit.
Bi valent pfizer booster was given by medical assistant  instead of 2nd pfizer vaccine in primary series dose.  No adverse events were noted from patient.
This spontaneous report as received from a healthcare worker, who is also the office manager, refers to a female patient of unknown age who was allergic to codeine, DEMEROL and penicillin (reactions unspecified). There was no pertinent medical history. On 10-JUN-2013 the patient was vaccinated with ZOSTAVAX lot # J001008 and expiry date 24-APR-2015, via subcutaneous route for vaccination. Dose was unknown. Concomitant therapies included ATIVAN and DEXEDRINE. Sometime after vaccination, on an unknown date in 2013, the patient developed one painful varicella lesion on the right upper side of her buttocks. The office manager reported that the lesion resolved on an unspecified date. Packet was offered but healthcare professional (HCP) was adamant about not receiving because the lesion has resolved. Packet was not faxed. The outcome of one painful, varicella lesion on the right upper side of her buttocks was reported as resolved. Treatment given and lab diagnostic studies performed were none. Medical attention was not sought. Additional information has been requested.
Pt received PNEUMOVAX at 09:59 on 2/6/12 in left deltoid. No immediate problem, but said his arm really started to ache & feel hot around 4:00 pm. Pt called here & was told to take BENADRYL, but forgot he couldn't due to his prostate. Seen this a.m. by dr. Rx'd with prednisone.
expired ACT-HIB was inadvertently given  with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently given  with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had some other health issues (ill-defined disorders)   On 04-Aug-2022, the patient received 0.25 ml dose of suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength, (frequency: once) ( lot:  UJ661AAA ; expiry date: 06-May-2022)  via intramuscular route in the right arm for immunization.  It was reported that an expired Act-hib was inadvertently given  with no reported adverse event (expired product administered) (onset date: 04-Aug-2022) (latency: same day). No other vaccines were given  Action taken: not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Pt was admitted to the hospital on 7/9/21 c/o pleuritic chest pain and was diagnosed with a Left sided pulmonary emboli. Because of her history of cerebral aneurysms she was treated cautiously with lovenox/Coumadin bridging at the direction of neurology. She was discharged home on 7/12/21  to follow up with her primary care with close blood work monitoring. Her venous dopplers were negative for deep vein thrombosis. She has no prior history of blood clots, does not take birth control, no family hx of blood clots, does not smoke, has had no recent/prolonged immobility or travel and no recurrence of cancer that has been in remission for 8 years, no obesity.
Numbness of his limb; This is a spontaneous report received from a contactable reporter(s) (Other HCP) Nurse from medical information team.  A 65 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 08Sep2021 16:15 (Lot number: EW0182) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset 11Sep2021, outcome "recovering", described as "Numbness of his limb". The event "numbness of his limb" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoesthesia.  Additional information: A 65year old male patient received his first dose of Pfizer BioNtech covid vaccine on 08Sep2021 and he reported numbness of his limb on 11Sep2021. The physician has prescribed gabapentin for the patient but they want to know regarding the timing for the second of the Covid vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Pt reports numbness in limbs 3 days post vaccination. Patient received treatment received for the adverse event ;Gabapentin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient has not been tested for COVID-19  No follow-up attempts are possible. No further information is expected.
~ 1 month After 2nd vaccine broke out in 2 different rashes saw 2 dermatologists and several other docs with no agreement ? the rash was not only itchy but painful  preventing sleep ( which caused loss of sleep getting sick and missing work etc) the rashes lasted over 6 weeks ? several weeks after my booster I broke out in some spots but nothing like the first time . Nothing lije this has ever happened before. I would say this was worse than or as bad as shingles .
Area of erythema approx. 4x 4? RUE appeared day following vaccine injection. Area warm to touch and itchy. , Redness increased in size on day 2.
Patient received a second dose of Bivalent vaccine. Patient originally stated that her last dose was given April 2022 (pre-bivalent release). After vaccination it was discovered patient had a bivalent vaccination in November 2022.   Patient did not report any adverse symptoms.