chrisvoncsefalvay/vaers-outcomes huggingface dataset:
22 minutes after the shot was given I began to have problems swallowing my own spit, I started to feel itchy. Brought to the attention of the nurse - who took me to the Medics on site. At that point I began showing signs of hives on my chest/body - was given injection of epinephrine and was immediately taken to Hospital by ambulance. they gave me additional epinephrine, stomach meds and continued monitoring for several hours.
c/o headache and fatigue after inoculation 10/30. 10/31 sore throat. 11/4 now has cough and temp 100 degrees. Seen HD provider - impression "questionable URI". Seasonal or H1N1 flu ruled out at present. No Rx given. 11/6 called mother. Child "much better- fine actually".
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-OCT-2016, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date in October 2016, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure, Herpes zoster) and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 30-OCT-2016, the patient had physician office visit for treatment of shingles. The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX.
Fever, aches, fatigue after waking. swelling at vaccination site day off and into next day.
Pt strated to experience swelling, pruritus, erythema, and warmth 4 days after vaccination.  Pt says sx's are getting worse.  Treated patient with cipro 500mg po BID x 7 days, benadryl, and hydrocortisone cream
Client noted that approximately at 11:45PM on 04/01/04 she experienced itching, hives and pressure on chest. Had to sit up in recliner all night to sleep. Symptoms lasted approximately 12hrs. No treatment sought.
PT had persisting shoulder pain/weakness/discomfort, difficulty sleeping due to pain. She did not respond to pain meds/rest/stretching/time. She tried nsaids/pain meds/steriods and was evaluated by a PMR doctor and orthopedic shoulder specialist and underwent MRI. This showed a full thickness tear in the left  suprspinatus tendon and partial infraspinatus injury and bursal edema. This was felt by me and patient to be consistent with SIRVA injury "shoulder pain after vaccine administration" . The patient underwent surgery to repair this injury early August 2016.
Information has been received from a mother concerning her 16 year old daughter with allergy to Amoxicillin no pertinent medical history and no concomitant therapy reported, who on 04-Mar-2008 was vaccinated with the first dose of GARDASIL 0.5ml and experienced swelling, redness and feeling hot from her shoulder to elbow in the injection arm. On 09-May-2008 received her second dose of GARDASIL 0.5ml and experienced rash and hives which have not gone away. On 05-Sep-2008, received the third dose of GARDASIL 0.5ml and experienced her arm swelling again. The patient sought medical attention, physician. At the time of the reporting the patient had not recovered. Additional information has been requested.
Phone call from husband on 3/12/21 at 2:43 pm that after leaving the Health Department around 12:20 pm they drove to restaurant and his wife ate lunch.  They drove home and she was resting in living room and he found her at 1:30 pm unresponsive.  He called ambulance and she was transported to the emergency department at Center.   He reported that the doctor was running tests and he would let me know what they find out.   3/16/21 3:45 pm phone call to, husband and he said patient was sent by flight for life to Center on 3/12/21.  He reports that it was determined she had a seizure and then had another in the emergency department and was intubated due to low oxygen levels.
Sore arm but better.; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm but better.) and HEADACHE (headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for an unknown indication.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm but better.) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Sore arm but better.) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the concomitant medications were not provided. the treatment information was not provided.
1 hour after leaving office child had twitching and foaming at the mouth 911 was called. Took to hospital. Follow up in our office 3/29/13.
felt very weak/ shakey.  Chest was tight and felt a warm sensation going thru body like a dye from a cat-scan. Bad headache.
Janssen COVID-19 Vaccine EUA Chills and intense shivering, nausea, headache, and fever. Had a 102.6 for a couple hours
Area near injection became red, swollen, itchy and tender 7 days after the injection. Area is about the size of a grapefruit.  It has been this way for three days so far.
SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN  REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Information has been received from a nurse concerning a 32 year old female. On 07-OCT-2013, a pregnant patient was vaccinated with GARDASIL (Lot# J002641, expiration 10-DEC-2015), 0.5 ml, intramuscular. The patient was mistakenly administered GARDASIL instead of Hepatitis B vaccine. On 09-OCT-2013, the nurse notified the patient and the patient informed the nurse that she is pregnant. The LMP and EDD was not reported. Additional information has been requested.
a little swollen on her armpit on the opposite site; she has like a little lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "a little swollen on her armpit on the opposite site"; VACCINATION SITE MASS (non-serious) with onset 2021, outcome "unknown", described as "she has like a little lump".  Additional information: Reporter stated that had a question my daughter she was 16 years old and she received the Pfizer vaccine, she received the vaccine on the April 22nd that was the second dose but she told me that she had like a little lump, she received the vaccine on the left side her arm the left and that she had things like a little swollen on her armpit on the opposite site. No, it was not on the same side it was on the other side on the armpit of the left reporter mean on the right side and she received the vaccine on the left side. Reported was just going to know if that reaction was normal the effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her approximately 16 month old son with chronic constipation before receiving ROTATEQ and with no drug allergies who on an unspecified date was vaccinated with ROTATEQ (lot # not reported). There was no concomitant therapy. After the vaccination her son had been experiencing diarrhea. The patient went to emergency room but not admitted. Stool sample was collected for test no result provided. He still had diarrhea occasionally. At the time of the report, the outcome of the event was unknown. The consumer also mentioned that her son "always got sick after receiving vaccines". In the past, the patient developed a fever and seizure while on prior therapy with hepatitis B virus vaccine (WAES# 1006USA00380). No further information is available.
18 days after vaccine developed pruritic spots. Admitted to Diagnosis: ITP. 12/12/07-records received for DOS 9/29-10/1/07-DC DX: Acute idiopathic thrombocytopenic purpura, questionable measles/mumps/rubella induced. C/O rash started 6 days prior to admission. Petechia all over face and body.
Reaction to 1st- 10 days after - achy muscles & bones , swollen glands, SOB -  felt like I had Covid again. Lasted 3 dsys  Reaction to 2nd - super achy muscles & bones, SOB, breathing pain, swollen glands, low grade fever, headache, ears hurt, burning watery eyes, itching around injection site  -  felt like I had Covid again but worse
After receiving the vaccine, I waited in the facility for 15 minutes as instructed by my company and the staff who administered the vaccine. When I left and got a few miles down the road, I started to feel my heart increase and I became short of breath. My heart rate was fast and pounding. My mouth started tingling and then I started feeling the tingling on my chest and neck. I started sweating and then started to panic and called 911 because I didn?t think I would make it back to the vaccination site or to the hospital in time. When the ambulance got to me I was still experiencing tachycardia, mild shortness of breath and tingling. The symptoms started to subside after approximately 20-30 minutes after they started. The paramedics assessed me and my blood pressure was 170/90 and HR was in the 120?s. I declined to be sent to the hospital due to my symptoms subsiding
she had with the Shingrix and Pfizer-BioNTech Covid-19 Vaccine somehow made her hot flashes disappear.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Hot flashes from an unknown date and unknown if ongoing (She said the she believes the reaction she had with the Shingrix and Pfizer-BioNTech Covid-19 Vaccine somehow made her hot flashes disappear). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced she had with the shingrix and pfizer-biontech covid-19 vaccine somehow made her hot flashes disappear. It was reported a few days after receiving both the Shingrix and the Pfizer Covid vaccinations her hot flashes disappeared. She had moderate reactions to both vaccinations that lasted 12/36 hours respectively. The good part was that her hot flashes disappeared from the time the reactions began and they did not reappear for 1-3 days after symptoms disappeared. She said it would be great if one could find a correlation and eventually provide a permanent treatment for hot flashes. The patient said she sent an email to Pfizer and got a response. She said she believed the reaction she had with the Shingrix and Pfizer-BioNTech Covid-19 Vaccine somehow made her hot flashes disappear. With this, she said it would be great if Pfizer would develop a medication for hot flashes since there was no current cure for it yet. Serious was reported as no. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot been obtained.
Swelling, redness and pain to touch that involved entire anterior thigh of leg that received DTaP. Required antibiotics for possible cellulitis, NAID, Ice.
Patient had an allergic reaction, including severe swelling and difficulty breathing. Patient went to immediate care and was treated. Patient given medrol dose pack and benadryl.
shortness of breath; swollen legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (swollen legs) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 069F1A and U03A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 15-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 microgram. On 26-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (swollen legs). At the time of the report, DYSPNOEA (shortness of breath) and PERIPHERAL SWELLING (swollen legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient could now walk 100 feet and had to stop and catch my breath. It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not reported.
Patient received Bivalent Pfizer vaccine lot # GK 1657. Upon completion of vaccination  and patient departure, this nurse noticed that the vial did not contain the 1.3 ml sterile water required for dilution. Vial removed from used. RNM notified as well as Provide. Per RNM vaccine error reported through VAERS.  Parent notified, no symptoms reported at this time. Parent will monitor and f/u if symptoms develop or have questions
Received ZOSTAVAX vaccine 8/28/09 per her request - 9/3 developed a "rash" along left rib and back area - Saw Dr. in clinic on 9/4 with large area involvement along T9 - T10 dermatome - Herpes Zoster rash diagnosed by Dr. - occurred 5 days after ZOSTAVAX vaccine
I have a fever; my current temperature is 102.6; Pulse is slightly high; I am not in the best of shape right now; Really tired; Hurting; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received  the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration in Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  In Jan2021, the patient had a fever,  her current temperature was 102.6; pulse was slightly high; patient not in the best of shape right now was kind of really tired and hurting. The patient's oxygen level was okay, checked it and it was around 96, 97 oxygen saturation. The patient further mentioned that the current temperature was real quick, patient was hoping to be around 100 but it spiked up as current temperature is 102.6. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
This case involves a six-month-old male patient who received second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination two weeks and 1 day later instead of 4 weeks on 09-Mar-2021 (inappropriate schedule of product administration). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 22-Feb-2021, the patient also received a first dose of the same vaccine (lot UT7081KA and expiry date: 30-Jun-2021) via an unknown route in an unknown administration site for prophylactic vaccination. The physician asked should the child be revaccinated. This was a case of actual medication error case due to drug dose administration interval too short (latency same day). At the time of reporting, 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 holders 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.
Narrative:  COVID infection following COVID vaccine series 12/08, Moderna , dose #1 07/12, Jansen , dose #2 12/30 COVID swab, result: detected 08/03 pt cc: cough/congestion/fever/SOB: +COVID contact at home 1/2/2022 pt admit Medicine cc: cough/congestion/fever/sob dx: Acute hypoxic respiratory failure due to COVID PNA LOS: 7 days 1/02 CXR IMPRESSION: Extensive increased patchy opacities are present throughout both Lungs. No pleural effusion or pneumothorax is identified. Cardiac silhouette appears stable. There is slight elevation of the left hemidiaphragm. 1/02 CTA PE: 1. No evidence for pulmonary embolism. 2. Severe diffuse groundglass opacities in the bilateral lungs with additional tree-in-bud nodular densities in the lung bases. Findings are likely related to COVID pneumonia given history. Consider follow-up imaging after treatment completion to ensure resolution. 3. Enlarged mediastinal and hilar lymph nodes, which may be reactive. Attention on follow-up. 1/02PT/APTT/INR: 14.2/29.6/1.27 1/02 BNP: 246 1/02 ABG: i-pH: 7.42, i=PCO2: 34.7, iPO2: 43, i-HCO3L 22.5 1/02 FIBRINOGEN:>1000 1/02 DDIMER: 1.65 1/02 LACTIC ACID: 1.39 1/02 PROCALCITONIN: 13.46 1/03 ESR: 106 1/09 PROCALCITONIN: 0.09 1/09 FIBRINOGEN: 277 1/09 DDIMER: 3.01 1/10 PROCALCITONIN: 0.06 1/10 FIBRINOGEN: 243 1/10 DDIMER: 3.21 1/11 FIBRINOGEN: 271 1/11 DDIMER: 2.20 1/11 FIBRINOGEN: 222 1/11 DDIMER:3042 1/11 ESR: 15 1
Low grade fever, muscle aches, headache, nausea (vomiting) , chills (shivering), exhaustion.  These occurred about 8 hours after the shot and were resolved within 24 hours of the shot.
Case PHEH2016US026437 is an initial spontaneous report received from pharmacist on 10 Oct 2016. This report refers to 45 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618701, expiry date not reported) at a dose of 0.5 ml intramuscular on 10 Oct 2016. On the same day, it was reported that the two patient received FLUVIRIN that reached to 76 Fahrenheit (F) for up to 13 hours. No adverse event was reported due to the maladministration. The seriousness of the event was reported as non serious.
Patient reported pain in Right arm that started the day after his injection.  He states it starts at his shoulder and sometimes causes tingling/numbness that radiates down his arm.
Large red, swollen, painful to touch circle at injection site that keeps getting bigger.  Headache, 102 fever, chills.  All but injection site has recovered after 24 hours.
Mom put the baby in bed with her at midnight because he was fussy,  Mom woke up in the morning and found the baby under the covers looking lethargic.  She then called 911 and baby was taken to the emergency room.