chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADACEL was given to 3 years old child patient/ no AE; Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (MI) (Reference number- 00794567).  This case involves a 3 years old patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] product administered to patient of inappropriate age.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day)  At the time of reporting, no adverse event reported.  It was reported "Caller is requesting information regarding administration of ADACEL to a patient under the age of 10years; caller verified the age of patient is 3 years of age; caller would like to know what precautions and adverse reactions to look out for as well as when to administer the age appropriate DAPTACEL if necessary".  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 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.  There will be no information available on the batch number for this case.
I was fatigue and muscle aches and pain in left arm. It lasted for about 2-3 days. The first day about 4hrs after getting the injection I developed a high ringing noise in my left ear and it is still present to this day.  Ten days after getting the vaccine my allergies got really bad and I had to increase my meds it lasted for about three days.
four month did not receive HIB part of Pentacel injection, No AE; Initial information was  received on 02-Mar-2020 regarding an unsolicited valid non-serious case received from the other  healthcare professional.  This case involves a four month old female patient who did not receive HIB part of Pentacel injection, while adminstration with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for Immunisation.  On 24-Feb-2020, the patient received a second dose of 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]  (frequency once, lot number UJ058ABA and expiration date 13-Oct-2020) but did not receive HIB part, via an unknown route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique.  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 holder's compliance with the requirements set out in Directive and Module VI of the 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.
Pruritic rash on trunk and difficulty breathing & wheezing. Administered BENADRYL and nebulized XOPENEX. Rash improved & breathing improved prior to leaving clinic. Occurred within 30 minutes of administration.
3 hours post vax, the infant began to cry. Infant cried and screamed inconsolably for 3 1/2-4 hours, then improved spontaneously to usual state except for mild irritability.
Death within 24 hours.  5/18/07 Received medical records from PCP which reveal patient initial exam in office placed her on wt percentile 2 & ht percentile 14 w/weight of 5 lbs 10 oz.  Next vs of 4/12 for parent concern of weight loss.  Wt was 5 lbs 8 oz.  MD instructed on feeding & planned to hospitalize patient on 4/16 if not improved.  Next vs on 5/3 day of vax after having been seen in ER for abdominal pain & received suppositories in ER w/good results.  Dx w/constipation. Weight 6 lbs 13 oz.  6/12/07 Rceived vax record from pcp which confirms lot & dose # as reported.  6/21/07 Received autopsy report which reveals COD as SIDS.
My temperature was 104.1; injured; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "severe COVID", start date: 2020 (unspecified if ongoing); "on a ventilator" (unspecified if ongoing); "heart stopped" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (medically significant), outcome "unknown", described as "My temperature was 104.1"; INJURY (non-serious), outcome "not recovered", described as "injured". Clinical course: Back in 2020 the patient got hit with severe COVID. He was actually on a ventilator, his heart stopped three times, His temperature was 104.1 and he was a covid long haul. Even though he was still injured on duty.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received the first dose of BNT162B2(COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on 14May2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14May2021 the patient experienced barely walk (gait disturbance). In May2021, for a good 8-9 days under armpit and breast side of vaccine, swollen (swelling), still feeling pain and tenderness (pain), still feeling pain and tenderness (tenderness), pain under my arm pit (axillary pain), still tired (fatigue), lymph node swollen (lymphadenopathy). The patient was still tired and feel like it's not her, still pain under my arm pit, breast is not swollen, it's a little tender, not like it was last week. Still tired, pain under armpit, not going away, it's tolerable but not comfortable.  After this experience, the patient was hesitant to get the second dose. Her appointment was scheduled on 04June2021. The doctor said to wait an extra week. The clinical outcome for I could barely walk was unknown, and the clinical outcome for the events swelling, still feeling pain and tenderness, still pain under my arm pit, still tired, lymph node swollen was not recovered. Information on lot/batch number has been requested.
headache; nausea; fatigue; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the second dose BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 57-year-old as reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, nausea, and fatigue after receiving the second dose of the vaccine on unspecified date. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
A MA reported that a 23 year old female received an injection of Pnu-Imune 23 and Flu Shield (1999-2000) vaccines on 10/5/99. She, subsequently, developed a fever of 104F, vomiting and arm pain. Additional information received from the physician on 11/19/99, stated that the pt went to the ER on 10/6/99. On 10/7/99, she was seen by the physician who performed a CBC with differential and treated her with IV fluid rehydration. The pt recovered.
Had shot in left bicep muscle. Had cramping in arm, swelling and redness on entire upper arm, and pain stretching from my left ear down to my left hand. Within 5 days the pain, the redness and swelling were so bad that I could not move my arm. I went to the clinic again and they told me I would be fine and that this is common. There is still pain, redness, and itching around the injection site area, and I have not regained full use of my left arm.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty band-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a year after receiving dTpa vaccine, the patient experienced passed out (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the passed out and cough were recovered/resolved. It was unknown if the reporter considered the passed out and cough to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she experienced very scary coughing episodes and that went on for weeks. The patient was passed out from coughing 3 to 4 times, she took out a fan and side table with 1 of coughing episodes. The patient reported that her niece was trying to get pregnant and the patient had her TDap months before the time of reporting.
Vaccination site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; Dizzy; This is a spontaneous report from a non-contactable consumer. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 10Apr2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and unspecified allergy. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6Z06) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 05:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint, pain, fever, nausea, feeling unwell and dizzy. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events of vaccination site pain tiredness, headache, muscle pain, chills, joint, pain, fever, nausea, feeling unwell and dizzy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected
Patient was vaccinated 7 days early for his second dose of the Pfizer Covid vaccine.  He had received his first dose on 4/23/2021 and was scheduled for a second dose on 5/07/2021. After vaccine was administered, patient was sent to the observation area for 15 mins.  Upon filling out his vaccination card, the error was noticed. His Grand-mother present there with him was notified and patient left with no adverse reactions after observation.
August 31st had a tonic-clonic seizure at 5:00 am, had another one on November 10th 4:30am. Due to having a second one I was diagnosed with epilepsy
Received flu vaccine for 1st time ever on 10/18/08 at 10am. By afternoon had runny nose, eyes watering, difficulty swallowing, aches and lip swelling. Seen in our ER at 17:38 for allergic prescription. Given BENADRYL, SOLU MEDROL and PEPCID and discharged. Better by 10/19/08.
3 hours after vaccine axillary temp was 100.6, 10 hours later 101.0, 12 hours later temp was 104.0. Mother gave Tylenol and sponge bath q 30 mins till temp was 101.  Child was lethargic and face looked swollen to the mother. The fever was 101.0 off and on the next day. Child not eating or drinking as much. Third day she still has temp. 100.6 with out Tylenol. Sixth day she is getting better; eating, drinking, and playing.
Blurry vision starting around April 4th,  abdominal pain, brain fog  & memory problems, shortness of breath weakness, swollen feet, general malaise, no appetite  Kidney cyst, liver nodule noticed in CT scan. Black toenails and pain in right foot.
This is a spontaneous report from a contactable consumer (parent). A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, and received dose 3 via an unspecified route of administration, administered in Arm Left on 04Nov2021 (Batch/Lot Number: FF2093) as DOSE 3 (BOOSTER), SINGLE (at the age of 19-year-old) for covid-19 immunisation. Medical history included ongoing juvenile idiopathic arthritis (Conditions: diagnosed 11 years ago). There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 19Mar2021 (at the age of 19-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Caller stated that her daughter had the, first two Pfizer Covid vaccines and after the second vaccine, her daughter developed a lump under her left arm, it was a rather large lump. She stated they could not figure out what it was, it did not really go away. Caller reported after the second vaccine arm hurt really bad all the way down her arm, it was her left arm. Caller stated her daughter just had a booster and the lump got bigger, it was really large, almost the size of a softball but maybe not as round, and her arm was really hurting again. Caller clarified that the lump appeared the day after her second dose of the vaccine. The outcome of events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
syncope/ vasovagal response. sweating, dizzy, then unconscious  for 15 seconds. was seated, so was placed lying down so as not to fall. return to normal after 15 seconds, with slight nausea. recovered fully after 10 minutes with water.
I had a cough, congestion, fever, body aches, extreme fatigue. I used a home a COVID-19 test came back positive. I called and had a telehealth visit. Once the COVID-19 started to clear, it seems it moved in my ear, nose and eye. I got an ear, nose and eye infection. I had to two follow-up telehealth visits and one in person visit. I was given eye drops to help clear up the eye infection. I was referred to an ENT, upon examination. fluid was drained from ears. I was given ear drops to help try and keep the ear drained of fluids. I am feeling better, yet still congested and my ear still is not draining properly.
Narrative:  This patient received four doses of the Pfizer COVID 19 Vaccine in Jan/Feb/Oct 2021/Apr 2022. The patient presented to the ED on nausea and vomiting on 18 June 2022. The patient was admitted with COVID 19 and acute kidney injury. The patient was treated with fluids and was discharged in stable condition on 24 June 2022. Reported per EUA.
Severe elbow pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jul2021 09:30 (Lot number: EW0177) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "Back pain" (unspecified if ongoing); "Knee arthritis" (unspecified if ongoing); "Gastro" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Ceclor, reaction(s): "drug allergy"; Benadryl, reaction(s): "drug allergy"; Lexapro, reaction(s): "drug allergy". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Severe elbow pain". The event "severe elbow pain" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of arthralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
8 hours after getting vaccination: Chills, headaches, fever - took ibuprohen/tylenol 36 hours after getting vaccination: Coughing, right eyelid itching,  hives and swelling by the right cheek bone - took non drowsy allergy medicine
rash/swelling/hives  on left calf, around navel, and on left hand
Myalgia, Diarrhea, NauseaVomiting, HYPOtension, Tachycardia, Fatigue, Chills Narrative:  Other Relevant History:
02/10/2021:  Weakness, fatigue, headache, myalgia, bilateral bleeding from ears. 02/28/2021:  Weakness  that I had to use a walker to ambulate (normally ambulate independently), dizziness/vertigo, sore gums, weakness more pronounced in lower extremities below knees.
Immediately after 1st pfizer vaccine patient stated he felt weird, then appeared to lose consciousness and possibly have a seizure.  He came to, reported that this had happened in the past when receiving a vaccine.  Paramedics were called and patient was taken to hospital with extremely low blood pressure.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 14:00 as dose 1, single (Lot number: en6208), in left arm, on 05Apr2021 at 13:00 as dose 2, single (Lot number: er8737), in left arm, on 13Nov2021 at 14:00 as dose 3 (booster), single (Lot number: fh8020), in left arm and on 03May2022 at 14:00 as dose 4 (booster), single (Lot number: fk9894) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "known allergies arugula" (unspecified if ongoing), notes: known allergies arugula; "known allergies walnuts" (unspecified if ongoing), notes: known allergies walnuts; "known allergies eggplant" (unspecified if ongoing), notes: known allergies eggplant; "known allergies peppers" (unspecified if ongoing), notes: known allergies peppers; "Meniere's disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Experiencing rebound Covid after taking Paxlovid; (unspecified date) Negative, notes: Texted positive after testing negative; (23Jun2022) Positive, notes: Texted positive after testing negative; (Jun2022) Positive, notes: Still testing positive on day 8 after treatment ended. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: The patient was treated with Paxlovid from 15Jun2022 to 19Jun2022. Experiencing rebound Covid after taking Paxlovid, fours days (23Jun2022) after ending the 5 day treatment. Texted positive after testing negative. Still testing positive on day 8 after treatment ended. No follow-up attempts are possible. No further information is expected.
BELL'S PALSY; This spontaneous report received from a consumer 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 (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported, administered 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the consumer mentioned in passing about a friend of a friend who received the Janssen COVID-19 vaccine and then developed Bell's palsy on an unspecified date. The action taken with covid-19 vaccine was not applicable. The outcome of Bell's palsy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210854887.; Sender's Comments: V0: 20210858509- Covid-19 vaccine -Bell's palsy. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
pt recv vax,got a large lump,redness & severe pain @ inj site,w/swelling & pale bluish skin;also had incontrollable crying 4-5hrs;to ER;also fussy all noc up & down;mom monitored sleep all noc to watch for sz (had no sz);
1)   Lymph node swelling under my left arm.  Discontinued using deodorant, swelling diminished after approx 3 days.   2)   on 4/12  I had a nose bleed ...  I don't recall ever having had one before. Some bruising has apeared on my right shin, and I don't recall hitting my shin.  After noticing it Sunday 4/18, a second large bruise appeared Monday 4/19.