chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per pt "Within moments of vaccine I developed a headache, felt like my heart was racing / pounding out of my chest. Quickly became short of breath, cough, nauseous and dizzy. I reported my symptoms to the RN in the observation room and took Benadryl. My HR was in the 130s at that time. I then used my EpiPen. They gave me 2 puffs of an albuterol inhaler and a 2nd EpiPen before taking me to the ER where IV allergic reaction protocol was initiated ( famotidine, iv fluids, solumedrol) and a 3rd EpiPen was given along with a duoneb and iv lorazepam. My symptoms improved after the 3rd EpiPen and seems to slowly resolve over the next 48 hours. "  Per ED note Patient is a 37 y.o. female presenting to the ED with shortness of breath and throat tightness. Immediately after getting a COVID vaccine today, patient developed sudden onset of shortness of breath, voice hoarseness and throat tightness. She gave herself IM epinephrine, Benadryl, and albuterol puffs through the inhaler prior to arrival. She was in her normal state of health prior to today. Patient has hx of vocal cord dysfunction, mast cell activation syndrome, and anaphylaxis, and has required epinephrine drips in the past with ICU hospitalizations. Has also needed intubation in the past.  Initial evaluation reveals patient to be tachypneic, tachycardic and anxious. +stridor and hoarse voice. Patient gave herself IM epinephrine prior to arrival along w Benadryl and albuterol puffs. Says her symptoms feel similar to what she has had before w anaphylaxis. Patient was given additional IV methyprednisolone, pepcid, Duonebs, and ativan. She was monitored and her work of breathing improved. No additional epinephrine was needed and patient was monitored in the ED for a few hours."
Patient felt constriction in airway and tongue swelling-took 4 Benadryl 25mg and went to ER where she was given an epinephrine injection and steroids.
Information has been received from a consumer concerning her 6 yr old daughter who, on 25Mar99 was vaccinated with a dose of varicella virus vaccine live. On 13Oct04 the pt developed about 3 to 4 dozen pimple like spots, some crusty, around neck, over torso, arms, legs and face. The consumer also reported a fever of 100-102F. The pt was seen by a healthcare professional (HCP) that same day and the child was diagnosed with chicken pox. At the time of this report there was no further information and the pt's status was unk. There was no product quality complaint. Additional information has been received from the reported administering/responsible physician's office stating that they did not give this pt the vaccine, nor did they see her for a reaction. No additional information is available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Apr2023) Negative, notes: Tested negative for Covid on home rapid test on Tuesday 04Apr; (07Apr2023) Positive, notes: Tested positive again at home on Friday 07Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: First symptom Tues 28Mar2023. Took Paxlovid as directed Wed on 29Mar2023 through that Sunday. Feeling better for a couple days. Tested negative for Covid on home rapid test on Tuesday 04Apr2023. Symptoms returned. Tested positive again at home on Friday 07Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
After 8 days of receiving the vaccine I developed a red, swollen, welt-like site about the size of a baseball around the injection site. It is warm and sore to the touch.
fever/lethargy began w/in 2.5hr of vax;fever climbed to 104.5 by 2AM following vax;MD referred to ER;pt seen @ hosp on24APR96;pt also exp severe localized swelling in thigh w/redness @ inj site;high pitched screaming for many hr;
Left arm pain on started on day 2 after vaccine and worsened with pain and limited range of motion that is still the case on 8/12/21.
Initial information regarding this unsolicited case was received from a consumer (patient) on 04-Oct-2017. This case involved a 70-years-old female patient who had chills, began vomiting every 10 minutes few months after and had hematoma at the related injection site unknown duration after receiving alirocumab (Praluent) delivered via alirocumab prefilled pen. No past drugs were reported. In Jul-2017, patient started to receive subcutaneous alirocumab injection, solution at a dose of 75 mg every other week (strength: 75 mg/ml) delivered via prefilled pen for elevated cholesterol. On Thursday, 21-Sep-2017 in the afternoon the patient self-injected alirocumab 75 mg into an unknown injection site. Then 2.5 hours later she began vomiting about every 10 minutes which lasted for 4 hours (latency: few months). Then she experienced chills which lasted throughout the night (latency: few months). The patient also experienced a hematoma at the related injection site (event onset: 2017 and latency: unknown). Two days earlier on 19-Sep-2017, she self-injected dulaglutide (Trulicity) at a different injection site; she had been receiving dulaglutide for about 1.5 years. On 07-Sep-2017, she received her flu vaccine. Other concomitant medications, all of which are taken orally: acetylsalicylic acid (Aspirin) 81 mg daily for cardioprotection, losartan potassium (Losartan) 25 mg daily for hypertension; and omeprazole (Prilosec) 20 mg daily for acid reflux. Action taken: no action taken and therapy was ongoing Corrective treatment: not reported Outcome: unknown Follow up report received from a consumer (patient) on 04 Oct 2017. It was reported as patient was vaccinated with a fourth injection of INFLUENZA VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 07 Sep 2017. (It was reported as patient received the flu-shot in between her third and fourth injection). On 21 Sep 2017, 14 days after the vaccination and about two hours after her fourth Praluent injection, patient vomited repeatedly for about 4 hours, and then Fell Asleep, and when she woke up patient was shivering, and could not get up to get her robe on. Patient also developed a Big Knot or Bulge on her arm at the Injection Site that stayed there for a week. On an unknown date, the day after the vaccination, patient was sick and lethargic, and could not get out of bed. On an unknown date, after the vaccination, patient also developed a huge Reaction. On an unknown date, patient recovered from the events lethargic, big knot or bulge on her arm at the injection site, huge reaction, could not get up to get her robe, terribly sick and chills/shivering. List of documents held by sender: none.
missed her 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 25-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd May 2018) and Twinrix (2nd dose received on 5th June 2018).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient missed her 3rd dose of Twinrix by a couple of years and still not received it, which led to incomplete course of vaccination. No lot available or expiration dates when asked. The reporter consented to follow up.
Narrative:  86 yo M with hx of CAD s/p CABG 5 vessel and recent cath ,COPD AFIB ,DM ,HTN ,HLD received 2 covid vaccines on 1/19/21 & 2/22/21. Pt died on 6/23/2021.Likely death not related to vaccinations given pt's advanced age, medical history & >90 days from last vaccination to date of death.
Did not go for 2nd shot; Passed out; Extreme arm pain; Could not lift up arms; Trouble with bowels; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not go for 2nd shot). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not go for 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment : Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Immediately after I was very exhausted, headache, then went to the ER and woke up blind, following the blindness and had a seizure. I was put on life supprt.
Information has been received from a healthcare worker concerning "about 4" patients (ages and genders unknown), who, on unspecified dates, were vaccinated with doses of pneumococcal 23v polysaccharide vaccine (lot # 658450/1380U expiration date 28-MAR-2009). Subsequently, the patients experienced redness and swelling at the injection site. The time frame is assumed to be from 24-JAN-2008 to present time. The healthcare worker and wholesaler requested a lot check. No other details were provided. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Pt states that at 1 am the day after the vaccine she started to feel dizzy, she started with diarrhea and felt ill all day Monday. Monday night when she went to bed she started with chest pain and cough. The chest pain would radiate to her back. Patient had never felt this pain before. she started taking a tea with ginger and lime. The chest pain lasted all day Tuesday and by Wednesday she only had a cough left.
Rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on 10Jan2021. Outcome of the event was unknown.  The following information on the lot/batch number has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 1:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 36 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  On 11-Jan-2021, the vaccine with batch number 041L20A was moved to fridge on 08-Jan-2021, 9 vials were moved to the clinic on 11-Jan-2021 at 02:00 PM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 07-Feb-2021..  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Developed malaise, runny nose  and productive cough with wheezing on day 3 following vaccination. Cough persisted for 5+ days. No fever.
2/8/2021 Spoke with mom, pt c/o of severe arm pain in same arm vaccinated in. Reports no ROM. Symptoms started 1 day after vaccination. On day 4, mom reports pain has improved. Facility will completed VAERS report. Referred pt to provider.
Clot blood; Diplopia; Headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received BNT162b2 (COMIRNATY), in 2021 as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 2021, for COVID-19 Immunization, reactions: "diplopia", "headaches", "blood clots". The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "blood clots"; DIPLOPIA (non-serious) with onset 2021, outcome "unknown"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches". The events "blood clots", "headaches" and "diplopia" required physician office visit. Therapeutic measures were taken as a result of thrombosis, headache, diplopia. Clinical course: The patient described various health issues following initial two-dose vaccine series and booster dose since 2021. Patient is an adult male approximately 40 years old. Patient described symptoms of headaches, diplopia, and blood clots that he recalled following vaccine doses and was actively being treated by his physician.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200069596 same patient/product/event, different dose;US-PFIZER INC-202201184242 same patient/product/event, different dose;
Client reports dizziness after the first few minutes after the first dose and that he did not report it and it resolved on its own within 15-20 minutes.
pt ended up developing retroperitoneal fibrosis that started with symptoms of right lower ext swelling in end of 5/2021. had ct scan to make the diagnosis done 7/1/21 and has since been started on steroids for the management of this.
Patient got the shot on 3/6/2021 2:30 PM. immediately after 5 minutes patient reported that her throat was closing.  I immediately took the Epinephrine 0.3 mg and administer to the left leg.    Patient said that she didn't feel anything on her leg.   After 1 minute, another dose of Epinephrine was administered and the technician called emergency responders. The paramedics arrived after 1 minute.  The patient was conscious and was able to breathe.  The paramedics brought the patient to the hospital for further observation.
Patient stated that he immediately felt light headed, but said he suffered from anxiety and was feeling a little anxious before the shot.  We watched him, gave him water and he seemed fine around 30 minutes after incident and left.
t/c from mom on 19JAN93 stating pt had rash on chest, stomach back & top of lip; stated noticed a rash on the face 18JAN94 around 7PM; mom unsure when rash appeared on chest, stomach & back; went to MD ?vax react;
PATIENT RECEIVED AN EXPIRED DOSE OF THE JANSSEN COVID-19 VACCINE ON 10/27/21.  PHARMACY NOTIFIED OF MISTAKE ON 3/06/2022. ATTEMPTED TO CONTACT PATIENT TO REVACCINATE BUT PATIENT HAS NOT RETURNED OUR CALL.
Woke up with what appeared to be broken blood vessels on  the left side of my left breast.  The next day the breast turned deep purple and looked like a large bruise.  Discoloration has lessened but it is still there.  There was no sensitivity to touch, no discomfort in the breast.  The left arm was sore at the injection side and under the arm.
Reddness, swelling around injection site about the size of a grapefruit, pain and itchy
This child presented at ER 12/2/06 with possible seizures. The doctor at Red Cedar Medical Center diagnosed gastroenteritis, dehydration and low blood sugar was cause of seizure. Mother reports child started vomiting 11/29/06 at 7:30pm and continued until she presented at ER 12/2/06. Rehydrated with IVs and given Albuterol updraft for asthma. Released after treatment 12/27/06-records received and reviewed for ED visit HX of decreased oral intake for 24 hours prior to ER visit, seizure prior to ER visit. Temp 99.2.  Assessment: gastroenteritis, probable mild dehydration and low blood sugar likely enough to cause seizure.
modern vaccine received 2/10/21; pt woke up with hives on chest 2/11/21
I started experiencing mild soreness around the injection site on the arm the next day after the shot and it lasted for a total of 2 days( which is very normal) . Then almost after a week I noticed a resurgence of very mild (weaker than the first time) soreness which lasted for one day and then disappeared again. As of now, I do not feel any soreness of pain. I am reporting this only because I felt it might add to the existing corpus of knowledge we have about the side-effects of the Moderna vaccine.
Within 5 minutes of shot my jaw and tongue started feeling numb, so I called them back over to ask if it was normal. Within a few minutes after that I told them my throat was starting to close up, I was having trouble breathing and both arms went numb. They said I was very pale, horse when talking and that they were going to start treating me for anaphylaxis due to my throat and airway issues. They immediately called for ambulance and  gave me 10 ml of liquid Benadryl and prepped an epi-pen. Within maybe 5-10 minutes the Benadryl help stop the throat closing and I asked them to not inject the epi-pen until the EMT arrived since the symptoms held and didn?t get worse.
Patient describes growing redness, tenderness, and warmth around injection site. Said she will go to doctor to get antibiotics. Called MD, will let him know. 2-18-17: spoke to patient, did not get seen. Claims her arm is completely healed back to normal.
severe aching in right arm with mild swelling and difficulty lifting arm, fever on day of vaccination and the following day
Arm was sore and had a knot at the sight of injection and was red. The next afternoon started feeling achy and couldn't get warm. Headache. Then, the next morning woke up and left arm pit is very sore.
Vomiting, headache, midback pain.   Symptoms still exist from date of vaccine to present No treatment
Patient complains of left arm redness, rash-like and slight swelling. Patient states arm is a lot better than at onset. Patient was seen in the clinic by doctor.
Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old female patient who received vaccine PENTACEL and it was mixed with sterile water and did not the HIB component. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunization. On 06-Sep-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5455AA expiry date: 18-Dec-2018 via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate reconstitution technique. No known symptoms were 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. List of documents held by sender: none.
Fever, severe body ache, chills, severe headache, severe pain in the arm, not able to stand up within 2 days after vaccine, pain in bones and muscles  - 2 days; Not fully recovered for a week and still feeling weak and having headache (taking medication, not helping much)