chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 15-AUG-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L049744, expiration date 12-OCT-2017, dose and route not reported). The vaccine was improperly stored at 55 degree Fahrenheit (F) for 16 days, 47.8 F for 13 hours, 50 F for 32 hours and then 47.8 F for 4 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Around 7pm, broke out in hives/welts throughout entire body. Incredibly itchy throughout. Skin flushed and warm to touch, felt like it was burning. Took 50mg benedryl PO, didn?t work after an hour, took 25mg more of benedryl and the reaction decreased. By next morning, still itchy but most of hives gone.
Patient had 103 degrees fever, vomiting, swollen neck gland, tired.  Mom observed jerky movements while sleeping.  Severe headache, redness, swelling at injection site, fussy.  Given Tylenol to help sleep.  Taken to doctor at 2PM and strep test was negative and diagnosed it as viral, but Mom disagrees.
PT'S LEFT ARM SWELLED UP ON AN AROUND SITE OF INJECTION, BECAME HOT TO TOUCH, AND VERY ITCHY. ON 10/09/12 PT DEVELOPED REDNESS, RASH, AND PAIN. AREA MEASEURED 40MM IN LENGTH AND 50MM WIDE.
the shipment was received outside the 72 hour guideline for standard shipping, it was received in 76 hours and was potentially compromised with no adverse event; the shipment was received outside the 72 hour guideline for standard shipping, it was received in 76 hours and was potentially compromised with no adverse event; Initial information regarding this unsolicited valid non-serious case via The Agency (reference number: 00303291) was received from other health care professional and transmitted to Sanofi 06-Oct-2020.  This case was linked to 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310464, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310559, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310708, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769, 2020SA310770 and 2020SA277871 (same reporter).  This case involved a patient with unknown demographics who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] prefilled syringe (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline, it was received in 76 hours and was potentially compromised (product storage error and product distribution issue). No thermometer was in packaging and product was cold when they received it.  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd flu vax & 48 hrs later pt devel hives which lasted 1 wk;
This is a spontaneous report from a contactable consumer. A 26-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 26Apr2021 at 07:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 12Apr2021 at 07:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 21:30, (also reported around 21:00 to 22:00) the patient experienced chills, dizziness, muscle pain, runny nose and fever throughout the night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) 600mg on 27Apr2021 at 06:00 and symptoms subsided. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, dizziness, muscle pain, runny nose and fever throughout the night were resolving 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.
Flat warm red rash on bicep area of arm that received vaccine. Patient went to emergency department. Patient reports he was given an injection of Bactrim. Patient also reports that staff in emergency department told him they have seen several patients with infections after receiving Prevnar 13 vaccine.
Hives at injection site pt itching, BP 98/65 P108 T98.5.
Patient reports numbness, tingling starting from the area of vaccination (left deltoid) and radiating to his left thumb and pointer finger.
Patient passed out and felt on the floor after receiving Covid 19 Moderna vaccine. Pulses were normal per pharmacy manager. Contacted 911, and the team came over and checked on him; they said he was ok. Pt stayed in the observed pharmacy area for additional 30 minutes and his mom picked him up.
flare of guttate psoriasis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GUTTATE PSORIASIS (flare of guttate psoriasis) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUTTATE PSORIASIS (flare of guttate psoriasis). At the time of the report, GUTTATE PSORIASIS (flare of guttate psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous report as received from a registered nurse refers to a 04-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Patients adverse reactions started day of vaccination with right arm pain up to right ear as well as complete tongue numbness. On 1-1-21 patient had increased Bell's Palsy symptoms including; inability to raise left eyebrow, inability to close left eye in its entirety,  teeth being numb on left side, and numbness and tingling in left foot and left hand (from palm to fingers). ER physician prescribed  on 1-1 Prednisone, Keflex and Valtrex. Patient went to ER again on 1-2-21 with lower extremity numbness on left side that is moving proximally toward her hip.  Patient went home on 1-3-21 with an RX for Prednisone as well as Valtrex. Symptoms have improved but have not fully resolved at this time.
he experienced fever and tested positive to COVID-19.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiry date: unknown) dose 1 via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Apr2021, (on travel to other country) he experienced fever and tested positive to Covid-19. The patient received unspecified treatment until 21Apr2021.On 08May2021 the patient tested negative to Covid-19. The patient wants to know if he can take the second dose tomorrow or the day after as he came back to his own country. Outcome of the event was resolved on 08May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
felt stabbing in back, pain around ribs and heart area, lasted through night, got better next day, though she was having heart attack
Started with sneezing then progressed to nasal congestion alternate with runny nose, watery eyes, mouth breathing and chest tightness with occasional non-productive cough with pressure on head which she attributes possibly nasal congestion, denies fever, SOB.
2/26/04 Admitted to facility. 8/19 examined for possible atrial fib; results on EKG. 10/17 complained of chest pain, pulse 115-130; admitted to hospital. EKG showed atrial fib, rales (mild); Topol administered and stabilized. 10/20 Discharged. 10/24 Being given O2. 10/26 began moving self in wheelchair; no complaints.   Nurse follow up on 11/01/04 states: "anemia; dementia; depression; constipation; mitral valve disease." Follow up 01/19/05: Patient has not recovered. Activity level did not recover, she continues to experience fatigue.
There is no adverse reaction. Pt was given the wrong vaccine- Infanrix. This was erroneously pulled from the fridge and given with the Adacel and HPV.  She was supposed to be given Adacel, HPV, and Menactra.
I received my COVID-19 booster on 12/07/2021 in the morning. I had two vaccines from Pfizer and my booster was from Moderna because Kaiser had a delay in the Pfizer shipment. I decided that given FDA approval of mix and match to go ahead with the Moderna booster. This resulted in me nearly fainting because I became light headed and dizzy with sweat throughout my body. I was feeling hot and my head was hurting immediately. I was unable to get up because of this. This lasted for 10-15 minutes. I was taken by ambulance to the emergency room and noted to have an elevated white count and abnormal EKG. Currently I am being followed by physicians to see if this led to complications.
Approximately 10 minutes after receiving all vaccines, patient who had been very nervous became lightheaded and collapsed.  She was quickly awakened with stimuls and talking to her and getting her talking.  After discussion with parents it was learned that she had been waiting for the shots for school for some time and had not eaten or had anything to drink.  Stimulation, observation and support continued for approximately 20 minutes.  AT no time did she stop breathing.  Patient left for home with her parents at 2 PM.
54-year-old female who was diagnosed with Covid several weeks prior presented to outside hospital due to facial numbness/tingling. She was found to have evidence of MCA stroke and was given TPA, she was transferred here for further management. Upon arrival here she was found to have evidence of bilateral MCA strokes, given that the patient was intubated and there is no likelihood of meaningful recovery goals of care discussions were had with neurology and the recommendation was to proceed with comfort care measures. The patient was extubated and transitioned to comfort care measures. Patient expired on 8/31/2021, cause of death was bilateral MCA strokes.
I felt fatigued after receiving the vaccine for about a week. I had a horrible headache and my throat hurt on 02/03/2023. I tested positive for COVID-19 on 02/05/2023. I contacted my provider and got a prescription for PAXLOVID. I tolerated the medication without any complications. As of today, I still feel fatigued, and I do have intermittent chest pains.
This spontaneous report as received from a male physician of unknown age with no pertinent medical history reporting on himself. In January 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. There was no concomitant medication. The physician reported that two weeks after vaccination, he was diagnosed with dermatomyositis. The physician felt lethargic, had neck pain and lost 17 pounds. The patient was treated with steroids. Muscle and tissue biopsies were performed (results not provided). At the time of the report, the patient was recovering. Dermatomyositis, felt lethargic, neck pain and lost 17 pounds were considered to be life threatening and disabling by the physician. Additional information is not expected.
Dizzy; Unbalanced when attempting to walk; Blurry vision; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 23Jan2021 (12:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the school or student health clinic. The patient had no relevant medical history. The patient had unspecified concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (21:00), the patient was dizzy; unbalanced when attempting to walk; and had blurry vision. It was unknown if the patient had received treatment for the reported events. The outcome of the events, 'dizzy', 'unbalanced when attempting to walk' and 'blurry vision', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
This case was reported by a healthcare professional and described the occurrence of twitch in a 6-month-old male subject who was vaccinated with Pediarix and MMR II for prophylaxis. Concurrent vaccination included PedvaxHib given on 3 May 2006. Previous vaccination included two doses of Pediarix given on 4 January 2006 and 3 March 2006. on 3 may 2006 the subject received 3rd dose of Pediarix at 0.5 ml in the left arm. On 3 May 2006, 5 hours after vaccination with Pediarix, the subject experienced twitching on his left side which the physician described as "drawing up head toward left." The event last for 10 to 15 minutes and then completely and resolved. The subject was seen in the physician's office and was advised to take Benadryl. The healthcare professional considered the events were a congenital anomaly. The following day, 04 May 2007, the physician who did not think this was seizure activity ordered an EEG just to rule out the possibility. The results of the EEG were normal. The healthcare professional considered the events were possibly related to vaccination with Pediarix. The reporter noted that when the subject received his MMR (Merck) vaccine when he was 16 months old, he started twitching, wouldn't stand, became irritable, glassy eyed and extended his head away from his body 30 hours after receiving the vaccine. The symptoms resolved. The subject did not receive any additional vaccines that day, nor has he received any additional DTaP vaccines outside of the 3rd dose as part of the Pediarix.
pt recvd vax;mom states, 3 hrs later,pt started sz like sxs, shaking, blank stare,peripheral & perioral cyanosis;to er, T 101.9;inject site w/o problem; f/u exam & neuro check 3apr95 in ofc by MD;
approx. 5 minutes after vaccination while sitting in waiting area, motioned to nurse monitoring area she felt tingling onher lips. No swelling noted appeared to then start to vagal and was lowered to floor when she started to have peti mal seizure activity which progressed to GM and lasted approx. 30-45 seconds. Then had several more episodes. transferred to our Urgent Care then via ambulance to ER.  Was able to talk between seizure. Had seen neuro that day for an appointment . Currently getting worked up. No meds at this time for seizures.
Swelling and redness of upper arm, around site of vaccine, extending from the deltoid to the elbow; began within 1 day of vaccine, and did not resolve for 5-7 days. No treatment required.
Patient given Varicella vaccine on 9/20/2000.  Patient's sibling received varicella vaccine on 8/27/02 and varicella rash appeared on patient on 9/5/2002.
Within a few minutes of receiving vaccine Pt. became ill, feeling shaky, nauseated, headache. Pt. disoriented, kept taking wrong way home - symptoms got worse,  projectile vomiting, diarrhea, severe headache, Blood Pressure very high, then very low, little to no appetite - finally resulted in hallucinations and seizures, Parkinson type movements - stopped breathing - respiratory arrest - had to be on life support - in ICU 4 days - Left with permanent seizure disorder, memory & cognitive issues - skin lesions that are big purple splotches at slightest impact to skin.
felt lousy; aches from head to toe; slight fever of 102; lump under her left arm; the worst chills she has had in a long time; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 18Feb2021 (age at the time of vaccination was 72-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date (age at the time of vaccination was 72-year-old) as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced felt lousy, aches from head to toe, slight fever of 102, lump under her left arm and the worst chills she has had in a long time. The caller stated she received the second dose of the vaccine yesterday and has felt lousy since yesterday evening. She aches from head to toe, has a slight fever of 102, a lump under her left arm, and the worst chills she has had in a long time, and she still feels kind of bad. Consumer stated, I got my second Covid shot (Clarified as Covid 19 vaccine) yesterday Pfizer and I was feeling warmed. I got to see was I had a little temperature of 102 and I ache from head to toe and I have got a lump under my left arm which was where I got the injection. I was looking at all the literature that was given and it does not say anywhere in there that I can take. Can I take Ibuprofen or acetaminophen or aspirin to get rid some of these thing. I do not want to take something that is going to be wrong, but I like to. When paraphrased the concern, Consumer stated, Absolutely, yes. I can't move and this lump under my left arm I think is like (incomplete sentence). Everything hurts. On an unspecified date, the patient underwent lab and medical procedure which included Body temperature which showed result of little temperature of 102. Outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was kept in the refrigerator since 08-Oct-2021.
sore arm, injection site enduration, body aches, chills, fatigue, headache Narrative:  Took OTC advil
Feeling super anxious; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANXIETY (Feeling super anxious) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (On medication for extreme anxiety.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced ANXIETY (Feeling super anxious). At the time of the report, ANXIETY (Feeling super anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment for the event included risperidone to help her calm down.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Redness and swelling at injection site. Hard to the touch. Hard bumps at injection site, back, legs and feet.
Fever of 100-102, body aches, chills with muscle spasms, headache, fatigue
Fever, choking, coughing, nasal congestion, runny nose , irritable (2/23/2018) Speech delay - regressed from 100 words and 3 word phrases to 2 words: mom and dad (by 12/18) Also received 2 extra flu shots(11/8/2018, 12/11/2017, 1/8/2018),  an extra chickenpox vaccine(1/8/18, 12/11/2017), as well as an extra polio vaccine (DTap-IPV-HIB with pentacel (3/14/2018, 5/10/2017, 3/10/2017, 1/10/2017)