chrisvoncsefalvay/vaers-outcomes huggingface dataset:
History 5/1-15/19 5/1/15-  W- shingles Vaccine  upper Left arm near shoulder, band aid, upper thighs- small red spots and hives  BP 132/76 5/3/15 F  Injection site sore,  Rash, redness, hives, hot to touch, Upper Left and R arms- shoulder to elbow, lateral  5/4/19 Sat-  Urgent care-  BP 113/72 Rash spreading to splotches on both forearms- Injection site sore, RASH, ALLERGIC REACTION TO SHINGLES VACCINE, BENADRYL 25-50MG EVERY 6 HOURS AS NEEDED FOR RASH AND ITCHING, PREDNISONE X 5 DAYSRECHECK FOR WORSENING SYMPTOMS, TO ER FOR ANY ONSET OF SHORTNESS OF BREATH OR CHEST PAIN OR DIFFICULTY WITH SWALLOWING, SWELLING OF THROAT OR TONGUE.- info sheet to call VAERS- 1-800-822-7967 to report side effects 5/9/19 S- Rash spreading to trunk, upper and lower arms more swollen, small spots on upper chest, itching, insomnia,  5/10/19 F Urgent Care BP 131/60  Arms worstIncreased dark redness, upper arms starting to peel later side, rash growing to medial side of both arms, splotchy, under 1st peel red, hot to touch, stinging, rash moving down to lower leg-spots, thigh, hives connecting,  Medication: hydrOXYzine hcl 25 MG Tabs  Quantity: 30 Tab  Commonly known as: ATARAX  Started by: MD  Take 1 Tab by mouth three times a day as needed for itching/pruritis for up to 10 days.  Refills: 0  Medication: * predniSONE 10 MG Tabs  Quantity: 45 Tab  What changed: You were already taking a medication with the same name, and this prescription was added. Make sure you understand how and when to take each.  Changed by: MD  5 tabs (50mg) po qd X 3 days, then 4 tabs (40mg) po qd X 3 days, then 3 tabs (30mg) po qd X 3 days, then 2 tabs (20mg) po qd x 3 days, then 1 tab (10mg) po qd X 3 days  Refills: 0  Shingrix [zoster Vac Recomb Adjuvanted] Allergy    5/13/15- M-office visit-BP 122/73  Added Lidocaine to apply 1 x daily to ?cool down? reaction- gathered information to send to VAERS, pharmacy to send details to VAERS, Rash continuing to spread to back, neck, arms ¾ covered laterally, peeling sporadically upper and lower, red, abdomen, breasts, neck, upper thighs, lower legs small patches of peeling, Prednisone effects-day 3 50 mg, insomnia- 3 hours sleep,  5/15/19- Urgent care-BP  139/82 Rash continuing to spread laterally and down, Upper arms 2nd layer not as red but continuing to peel, stinging arms and thighs, more splotches on neck, swelling under chin. Instructions Use domeboro powder to make solution to apply compresses to skin. If continue to feel worse go to ED  5/18/2019. Upper arms peeling, fore arms peeling, tingling all day, abdomen and upper thighs still inflamed but not peeling yet.
Patient developed a rash and fever 4 days after his vaccine and was eventually diagnosed with Kawasaki disease with secondary HLH (hemophagocytic lymphohistiocytosis).
Information received on 06DEC2014 from a customer who submitted the following question on MerckVaccines.com. "I received the ZOSTAVAX vaccine last week at my physician's office. I know it is a sub-Q vaccine but the medical assistant gave it to me IM. I tried to stop her but she just kept going. Will I get as good immunity if the route was wrong? Should I get it again?" Follow-up information was received 08DEC2014 from a 65 year old female patient who is also a nurse. The patient called to report that she received a dose of ZOSTAVAX on 03DEC2014 via intramuscular route rather than the recommended subcutaneous route. The patient reported that she has a pre-existing condition of atrial fibrillation (Afib) and she only occasionally experiences it. The patient reported that she experienced afib on 04DEC2014, a day after receiving ZOSTAVAX. Also, on 04DEC2014, the patient noticed a small "pox (rash)", a liquid-filled lesion on the back of her neck which was very painful. The patient reported that only one lesion was noticed and she popped the liquid-filled lesion herself and put "aspirin-water mixture" on the lesion and now it is crusted over. The patient reported that she put aspirin tablet in the water, dissolved it and made a paste and put that on her lesion. The patient (also nurse) did not want VZVIP packet, however she did say she could be contacted for follow-up. Concomitant medication included metformin, lisinopril and SYNTHROID. The patient reported drug allergies to codeine and penicillin. No hospitalization or life-threatening or significant disability occurred. Additional information has been requested.
headache, sore throat, nonproductive cough, body aches, nasal congestion, sinus congestion. starting on 11/12/21
I went to the (Privacy) to get my 2nd Covid shot. I then went to the pharmacy for my booster and waited for 15 mins. Went home feeling fine. In January I was at the PCP office with my husband because he was sick. They sent him to the ER I drove him there.. while in the ER I tested positive for Covid as my husband we went home and were there for 5 days but we could not take care of each other anymore. So we went to the Hospital where I was admitted for 11 days due to double Pneumonia. After 11 days of hospitalization went home we had home health care. I am still not completely recovered from this.
have not been having regular periods anymore; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6208) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "childhood asthma" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies. Concomitant medication(s) included: DEPAKOTE; FOLIC ACID; VITAMIN D [VITAMIN D NOS]. Past drug history included: Cephalexin, reaction(s): "known allergies: cephalexin"; Bactrim, reaction(s): "known allergies: bactrim". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Mar2021, outcome "not recovered", described as "have not been having regular periods anymore". The event "have not been having regular periods anymore" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of menstruation irregular.  Additional information: Serious: No -Results in death: No Life threatening: No Caused/prolonged hospitalization: No Disabling/Incapacitating: No Congenital anomaly/birth defect: No. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Ever since receiving her Covid vaccines patient had not been having regular periods anymore. After her initial covid vaccine she thought it could just be a coincidence but after she received subsequent doses it was apparent that it was related. Patient still have not had a period after receiving last dose & her husband & she were hoping to have another child.
Thursday evening. May 9th I noticed a red bumpy, itchy rash on both my arms. It lasted through the night and I woke up with it. It shortly went away after I was awake. It came back in the evening of May 10th on both my arms and on my left knee. It again went away in the morning. It came back Saturday evening on my arms and both my legs this time. I took two Benadryl?s and it was gone by the morning. Sunday evening it came back. This time I had huge red welts/hives on my back, butt, arms and legs. I again took a Benadryl and it was gone by morning. As of today May 20th the rash has not returned. Prior to the rash I had not eaten anything different nor had I used any new products such as laundry detergent, soap, etc. When I got my 2nd shot on May 4th. I did experience a stiff/sore arm. The area of the injection was slightly swollen and sore/itchy for a few days after. I also experienced chills and body aches the day following my shot, May 5th.
p/vax pt exp soreness; fatigue; 3days later exp T102; night sweats; joint pain; 4/22 fever continued; 4/24 devel upper respiratory problems;
9JUK92 exp redness & swelling of the arm; also devel low-grade fever & exp difficulty rotating wrist; subsequently recovered; No further details were provided;
Swollen arm; red and raised rash about 3 inches around the injection; Extreme nausea; Shaky; Itchy; red and raised rash about 3 inches around the injection; Migraines; Swollen arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the first episode of PERIPHERAL SWELLING (Swollen arm) and the second episode of PERIPHERAL SWELLING (Swollen arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis autoimmune since an unknown date. Concomitant products included OMEPRAZOLE, PROMETHAZINE and METHADONE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MIGRAINE (Migraines), the first episode of PERIPHERAL SWELLING (Swollen arm) and NAUSEA (Nausea). On 14-Mar-2021, the patient experienced TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the second episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection). The patient was treated with HYDROCORTISONE (topical) at a dose of 2 %. On 04-Mar-2021, MIGRAINE (Migraines) and NAUSEA (Nausea) had resolved. At the time of the report, TREMOR (Shaky), VACCINATION SITE PRURITUS (Itchy), the last episode of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE RASH (red and raised rash about 3 inches around the injection), NAUSEA (Extreme nausea) and VACCINATION SITE ERYTHEMA (red and raised rash about 3 inches around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021 and 2/22/2021. Presented to the emergency department on 9/18/2021 for worsening hypoxia and fever. Recently diagnosed with COVID pneumonia and treated at a different facility. Upon arrival to ED, on 9/18/2021, patient was placed on oxygen 5L nasal cannula (increased from home requirements of 2L). Throughout hospitalization, respiratory status continued to decline and patient received: remdesivir, dexamethasone, baricitinib, and antibiotics.  Patient expired on 9/29/2021 at 1412.
short breath; Felt bad; red swollen 2by4 inches on her arm; hot at the injection site; allergic reaction; sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), VACCINATION SITE WARMTH (hot at the injection site), DYSPNOEA (short breath), VACCINATION COMPLICATION (Felt bad) and VACCINATION SITE ERYTHEMA (red swollen 2by4 inches on her arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (Swollen arm). On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot at the injection site), VACCINATION COMPLICATION (Felt bad) and VACCINATION SITE ERYTHEMA (red swollen 2by4 inches on her arm). On an unknown date, the patient experienced DYSPNOEA (short breath). On 08-Mar-2021, HYPERSENSITIVITY (allergic reaction), VACCINATION SITE WARMTH (hot at the injection site), VACCINATION COMPLICATION (Felt bad) and VACCINATION SITE SWELLING (Swollen arm) had resolved. In March 2021, VACCINATION SITE ERYTHEMA (red swollen 2by4 inches on her arm) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DYSPNOEA (short breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided
Minor chills Muscle aches tightness Throbbing joint pain in multiple areas. Exacerbated in areas where I already have chronic joint/muscle pain Mid grade fever Severe headache All lasted for 36 hours
RIGHT EYE SWOLLEN (NO PAIN ASSOCIATED WITH THE SWELLING BUT DID ENDORSE FEELING PRESSURE RELATED TO THE SWELLING); DISCOLORATION ON THE EYE LID AND OUTER SKIN SURROUNDING THE EYE; This spontaneous report received from a pharmacist concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  Non-company suspect vaccine (booster dose, series 2) included: BNT 162 (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 30-OCT-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 31-OCT-2021, the patient started having a strange reaction. The patient woke up and noticed that her right eye was swollen with some discoloration on the eye lid and outer skin surrounding the eye. The patient reported no changes in vision and no pain associated with the swelling but did endorse feeling pressure related to the swelling. It was stated that there was no drainage from the eye. It was told to patient to take a Benadryl (diphenhydramine hydrochloride) in the event that may be a delayed allergic reaction. At the time of reporting, symptoms were still the same with no improvement. It was advised the patient to see medical doctor for evaluation. The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The patient had not recovered from right eye swollen (no pain associated with the swelling but did endorse feeling pressure related to the swelling), and discoloration on the eye lid and outer skin surrounding the eye. This report was non-serious.
Headache, joint stiffness, joint ache, skin pain, skin turns a funny color at times, skin papules filled with clear fluid, when papules broke fluid burned skin and was extremely painful, vision, poor tolerance for bright lights.
pt recv vax & p/several hr redness & swelling was noted;by early the next day pin-prick sized hardened, red nodule had develop intermittent ice was applied to reduce swelling;
I had flu like symptoms, but by evening my pulse kept going up over 100 that night. My Fitbit informed me of this. I checked my blood pressure because I got curious. That night it was 152/116, and it kept going up and up. I went to the doctors office, and they ordered me some  medicine. But, then they told me to go to the ER. They did tests and told me I had sinus tachycardia and hypertension. They gave me medicine called metoprolol.  It slowly started to bring my pulse down to about 40, but kept jumping back up. Pulse was to low, so they switched my medication to losartan.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling all over, especially in her arms, pharmacist took blood pressure - reading of 136/106 with heart rate of 132, had patient lie down with knees bent, didn't seem to help, so called 911
I immediately tasted the vaccine , about an hour afterward, I began to vomit in a violent manner. I remained nauseated for about 3 more days.
Patient got a migraine hours after getting the SHINGRIX immunization, the patient went to sleep and within 12 hours after immunization when she woke up she felt dizzy and lightheaded, she called out for help to her husband while trying to walk to the bathroom, but she passed out as she made her way. He husband caught her when she fell down.
Shortly after receiving dose #2 ( approximately 2 to 3 weeks) I noticed a black spot to the left of my vision. It did not move (like a floater would) and I was just hoping it would go away. About 3  weeks after that it got bigger so I went to my Opthamologist who urgently sent me to a retinal specialist and informed me I had a "very rare" bleed in my eye.
pt recv vax SEP95 & in JAN96 pt devel a temp of 99.6 & a rash w/nodes in hair, on face, & poss in mouth which never blistered;
extremely sick; nothing tastes right; chills; fever; extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking); vomiting; swollen lymph nodes (swollen and sore) in right breast; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), VACCINATION SITE SWELLING (injection site swollen) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site swollen). On 20-Apr-2021, the patient experienced ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), PYREXIA (fever), MYALGIA (extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking)), VOMITING (vomiting) and LYMPHADENOPATHY (swollen lymph nodes (swollen and sore) in right breast). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 21-Apr-2021, VACCINATION SITE SWELLING (injection site swollen) had resolved. At the time of the report, ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), PYREXIA (fever), MYALGIA (extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking)), VOMITING (vomiting) and LYMPHADENOPATHY (swollen lymph nodes (swollen and sore) in right breast) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-066330 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066330:dose 1
pain; low energy; mild headache; mild nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: E99261), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 (at the age 82-year-old) as SINGLE DOSE for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced mild headache and mild nausea on 02Feb2021, low energy on 03Feb2021, pain on an unspecified date. Reporter stated that "He is calling about the covid 19 vaccine. He had his first shot yesterday afternoon at 2. He slept great. He had a mild headache last night and mild nausea. This morning he got breakfast, and it wasn't excruciation but still felt pain, as well as the nausea, and his energy level was not normal. As far as the headache, would it be okay to take Tylenol, and for the nausea can he take Phenergan or Dramamine, its not extreme but just uncomfortable. His First Dose of the Covid Vaccine was on 02Feb2021 at 2PM or 2:05PM. The mild headache started last night the same day. The Nausea started last night was mild, on the same day also. The energy level being low started today 03Feb2021". Caller confirms that "after the onset of events he took 2 tylenol last night at 7. He had a little sinus problem and took 1 of coricidin hbp sinus over the counter medication last night. Taking both together made him anxious. Thats why he is calling to find out in the morning. He does not want to take things close together". Outcome of the event pain was unknown and other were not recovered.  Follow-up attempts are completed. No further information is expected.
gave an expired pentacel to a patient today, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse via Global Medical Information (Reference number- 00712774) and transmitted to Sanofi on 05-Aug-2021.  This case involved 4-month-old female patient gave an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] to a patient today (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Nurse reports that the patient also received injection of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) on the other side and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) via oral route for prophylactic vaccination   On 05-Aug-2021, the patient received first 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ347AAA and expiry date: 30-Jul-2021) (Strength : standard) (Drug Interval Dosage : once)  (Form: Suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that, "Nurse would like to know what are the next step? Is re-vaccination necessary and how soon"?  This was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no 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.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 84-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, potassium chloride, omeprazole, Lisinopril/Hydrochlorothiazide, oxaprozin, prednisone and simvastatin. On 13th April 2018 11:00, the patient received the 1st dose of SHINGRIX .5 ml. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythema, chest pain and inflammation. On 15th April 2018, the patient experienced red urine. On an unknown date, the outcome of the erythema was recovering/resolving and the outcome of the red urine, chest pain and inflammation were not recovered/not resolved. The reporter considered the erythema, red urine, chest pain and inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he developed inflammation below the injection site. He started noticing symptoms on Saturday on 14th April 2018. On 15th April 2018 he observed red urine on early morning Sunday. His urine color had cleared up now, but had turned into more darker color. The patient counseled to follow up with his health care provider.