chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746426, A0746427A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot  number FD0809. The Public Health District, per guidance from the Department of  Health (ODH), Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the  dose of vaccine that you received is valid.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-APR-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 of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 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.
there was a lot change with Pfizer and the lot number may not of been given to the patient correctly.
Pruritic rash and local erythema x (times) 2 weeks, treated with PREDISONE 12/9/08.
Interchange of vaccination products; Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression. Concurrent medical conditions included Diabetes and Smoker. Concomitant products included METFORMIN for Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccination products) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient had grumpy and cranky voice.  patient had taken Pfizer as first shot
Several hours after receiving HPV #1, pt + nausea, lightheaded, dizzy, depressed, throat swelling.
The morning after the vaccine was given the patient experienced a larger than expected adverse effect profile and noticed he was given a full 0.5ml dose. He then realized he should have received a booster dose and reported his symptoms to the pharmacy.   His first two doses of the Covid vaccine were given at another location and the patient requested and reported needing a  "second" dose. This was confirmed at the time of administration and according to all information that was presented we thought the patient was receiving the correct dose in the series.   As we discussed his experience he acknowledged we had less than adequate communication. We checked in on him on 06/17 and he reported feeling 99% with resolution of nealry all vaccine related side effects.
inadvertently administered Fluzone qiv instead of the intended Fluzone high dose qiv with no reported adverse event; Initial information was received on 30-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 71 years old female patient who received inadvertently administered influenza quadrival a-b vaccine (fluzone qiv) instead of the intended influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Oct-2023, the patient received a unknown dose of suspect influenza quadrival a-b high dose hv vaccine (strength, expiry date, formulation, lot number not reported) via unknown route in unknown administration site and also received a dose of 0.5 ml of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot U8041CA, Expiry date : 30-Jun-2024, strength was unknown) via intramuscular route in the arm not otherwise specified for all Immunization and inadvertently administered fluzone qiv instead of the intended fluzone high dose qiv with no reported adverse event (wrong product administered) (latency : same day). The information on batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered fluzone qiv instead of the intended fluzone high dose qiv with no reported adverse event.  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.
HEADACHE; FEVER; MUSCLE ACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced muscle ache. On 07-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (units unspecified). On 08-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-MAR-2021, was recovering from muscle ache, and had not recovered from headache, and injection site pain. This report was non-serious.
Pt recvd 1st dose of Hep B vax on 26NOV91 & 18 hrs following the vax w/Hep B vax pt exp severe joint pain, weakness, extreme nasal congestion, exhaustion a low-grade temp, flu-like sx; unable to get out of bed; sx persisted for approx 10day
pt recvd vax on 4FEB92 & w/in 24 hrs devel localized reaction w/redness, mild edema, blisters, pruritus @ inject site, also had generalized fatigue; tx DPH;
Nausea, vomiting and diarrhea every morning beginning 6/30/2021. Patient states it is worsening and has led to decreased appetite with no weight loss.  Pt states it began after receiving second dose of Covid vaccine. Pt was ordered zofran and Pepcid  and ordered to follow up with gastroenterologist.
Patient complained of tingling sensation in bilateral wrist/hands with increase in symptoms of weakness 24 hours later. Also, began to have tingling in face and bilateral  feet. Patient was evaluated and transported to ED for further workup and consult with neurology.
Evening after flu vaccine bump on arm itchy; faded away, then rash on chest pinhead size pustules, then now around neck. No fever, no swelling, redness arm, no malaise.
Patient called up 4 hours after vaccine complaining of nerve pain down her left arm. She took some Ibuprofen.
Post vax fever 103.8, shaking, chills, flu-like achy feeling. The physician who administered vax, feel that this is a viral event, not a vax reaction.
Fever, chills, aches, dizziness, fatigue, and rash on neck, torso, legs, and arms. Tylenol and rest.
just a little sleepy; Woke up with extreme nausea; My arm felt like Id been stung by a hornet (throbbing, very painful, no change in appearance), 6am every thing was fine again, just flu shot type arm pain- very quickly got better over the course of about half an hour; Hot & cold flashes (not my typical fever feeling); At 01:30  shot received,  17:30  it felt like I had a flu shot; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD). The patient had no known allergies to medications, food or other products. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) and unspecified multivitamin; all from an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. At 01:30,  the shot was received and at 17:30, she felt like she had a flu shot. On 05Mar2021 at 02:30, the patient woke up with extreme nausea, her arm felt like she had been stung by a hornet (throbbing, very painful, no change in appearance) and hot & cold flashes (not her typical fever feeling). At 06:00, everything was fine again, just flu shot type arm pain- very quickly got better over the course of about half an hour and at 09:00, her arm was barely noticeable and she can move it just fine. Overall she felt great- just a little sleepy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events woke up with extreme nausea, at 01:30 shot received, 17:30  it felt like had a flu shot and hot & cold flashes (not my typical fever feeling) was recovered on 05Mar2021 at 06:00. The clinical outcome of the events arm felt like I had been stung by a hornet (throbbing, very painful, no change in appearance), 6am every thing was fine again, just flu shot type arm pain- very quickly got better over the course of about half an hour was resolved on 05Mar2021 at 09:00. The clinical outcome of the event just a little sleepy was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
03/23/2005- low grade intermittent fever 03/24/2005- Maculo papular erythematous exanthema- trunk, limbs, non-pemphigus, swollen retro auricular nodes bilaterally.
Patient participated in a mass vaccine event with the local school system administered by local pharmacy.  After the vaccine was administered the patient was instructed to wait 30 minutes so she could be observed by a school nurse.  She said she noticed her lips were beginning to feel numb and looked in the mirror and noticed her face was beginning to turn red.  The nurse came over to assess the patient when she noticed the patient was developing hives on her face and neck and her eyes were becoming swollen.  The fire department with a paramedic unit was on site and came over to assess the patient.  They did not administer any medications as their protocol did not call for medications if the patient was not having difficulty breathing.  In the meantime 911 had been called and an ambulance arrived on site.  The patient refused transport and the ambulance left the site.  The nurse, pharmacist, and school staff would not allow the patient to leave the site until further evaluation for approximately 30 more minutes.  The nurse and pharmacist insisted the patient receive 50mg of diphenhydramine orally, and she agreed to comply.  The patient's friend was on site and agreed to drive the patient home and stay with her for at least four more hours.  The friend was instructed to call 911 if any of the symptoms worsened.  The patient was provided with an additional 2 x 25mg diphenhydramine capsules to take in  case needed.   The nurse called the patient at 1pm, and the patient indicated her symptoms were resolving.  The nurse called the patient again at 3pm, and the patient indicated she felt much better. The pharmacist called the patient on 03/15/21 at 4:45pm for additional follow-up.  The patient indicated she felt "wiped out" all day on 03/13/21 but felt much better by 03/14/21.  The pharmacist instructed the patient that even though she did not have an anaphylactic reaction she should NOT take the second dose of the Moderna vaccine, and that she should not receive the Pfizer vaccine either.
anemia, fever & cough are reported in a pt who recvd 1 dose of fluogen vax; pt recvd vax on 5OCT93 & on approx 19OCT93 exp above sx; 26OCT93 lab test results show HBG was 10 & HCT was 29.2;
This spontaneous case, was initially received on 21-Feb-2018, was reported by other non-health professional and concerns an adult male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with H1N1 influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, after vaccination, the patient had mercury poisoning and was diagnosed with Graves' disease. The outcome of the events: Grave's disease and mercury poisoning was not reported.
no adverse event; HBP calling to report a misuse AE with an administration of a second dose of PROQUAD to a 15 year old.  HBP confirmed the patient has no symptoms and no further details to provide.  No other AE and no PQC; This spontaneous report was received from a nurse referred to a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.   On 28-JUN-2023, the patient was vaccinated with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). The patient has no symptoms and no further details to provide. No other adverse event provided (no adverse event).
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#152710) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Autism. Information received concerning a female who was vaccinated with one dose of the mumps virus vax live 'while she was pregnant.' The reporting pharmacist did not know at what point in the pregnancy she received the vax. It was noted that the pt's child is 3-years-old and was recently diagnosed with autism. The child sought unspecified medical treatment. Upon medical review, the child's condition was considered as "other medical event." Additional information has been requested.
Pt has a red, hot rash 12 cm x 16cm. It was very painful when touched. Pt also cranky.
involuntary movement of her head and tongue. No previous hx of Tourette's syndrome; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 16 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Apr2021 08:30 (Lot number: ER8729) at the age of 16 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing); "Stone fruits allergy" (unspecified if ongoing). Concomitant medications included: LEXAPRO; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: DYSKINESIA (non-serious) with onset 17Apr2021 17:30, outcome "not recovered", described as "involuntary movement of her head and tongue. No previous hx of Tourette's syndrome". Therapeutic measures were not taken as a result of dyskinesia. Additional information: It was unknown if patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are needed. No further information is expected.
Minor psoriasis on feet; Second Moderna vaccine gave flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Minor psoriasis on feet) and INFLUENZA (Second Moderna vaccine gave flu symptoms) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third 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) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Minor psoriasis on feet) and INFLUENZA (Second Moderna vaccine gave flu symptoms). At the time of the report, PSORIASIS (Minor psoriasis on feet) had not resolved and INFLUENZA (Second Moderna vaccine gave flu symptoms) had resolved.            Concomitant drugs were not reported. Patient had received the booster dose, second dose and first dose of Moderna vaccine.  Patient had stated itching had gone away however she still had some minor psoriasis on her feet. The reporter's causality for the event of Minor psoriasis on feet with SKYRIZI (Risankizumab) was a reasonable possibility.  Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recvd vax 26JAN93 & w/in 2 minutes of vax devel a wheal of 1.5 cm & flare of 5 cm in diameter @ inject site; w/in 30 mins sx disappeared;
hands and arms shaking; headache; sleeping the whole time; chills; Tremendously fatigue; Teeth chattering; a high fever/high temperature; Cold feeling; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization, reaction(s): "I had no reaction"; Bnt162b2 (Second Dose), for Covid-19 Immunization, reaction(s): "chills", "tremendously fatigue", "Incredible cold feeling", "headache", "Fever", "my hands and arms were shaking". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 16Dec2021, outcome "unknown", described as "Teeth chattering"; PYREXIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "a high fever/high temperature"; FEELING COLD (non-serious) with onset 16Dec2021, outcome "unknown", described as "Cold feeling"; TREMOR (non-serious) with onset 19Dec2021, outcome "unknown", described as "hands and arms shaking"; HEADACHE (non-serious) with onset 19Dec2021, outcome "unknown", described as "headache"; HYPERSOMNIA (non-serious) with onset 19Dec2021, outcome "unknown", described as "sleeping the whole time"; CHILLS (non-serious) with onset 19Dec2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 19Dec2021, outcome "unknown", described as "Tremendously fatigue".  Additional information: The first time that I received the shot I had no reaction, second time I received the shot I had fever and chills, the usual stuff that people get. When I got the booster shot just recently and this was 8 month after my initial two shots. I did get the same reactions which was my teeth chattering, a high fever, an incredible cold feeling and shaking that lasted like 24 hours and went away. 4 days later I got the same thing and it lasted, I also had a headache and I was sleeping the whole time. I was 'online' I can't find anything about anyone getting a secondary reaction to any of these shots the way because I went, I had my shot on Wednesday because I had Thursday off, and on Thursday it went to well then I have get back to work on Saturday and Sunday. And then on Sunday morning was when I received the secondary reaction which was 4 days after. So I have not seen anywhere in any literature, anywhere that happening, but I wanted to know if that is happening because I know it was exactly the same thing, I had a high temperature, I had same exact feeling with chills, the teeth chattering, my hands and arms were shaking, I had a headache and always tremendously fatigue is the same thing that I had after my second shot and it was the same thing that I had within the 24 hours after my booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.