chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WRONG DRUG (wrong manufacturer) Administered in error. (administration error) on 11.26.21 Patient is 7 years old.  Was administered Moderna vaccine instead of Pfizer COVID-19 vaccine.  11.26.21:  Mother called nurse triage line - no symptoms reported at the time.   Confirmed with PCP that no serious side effects to be expected and what to watch for and to report.   on 11.27.21:  Mom said he had a low grade fever over the weekend that has improved. Mom is concerned because he is complaining of dizziness. Mom said she has been pushing fluids. She sent him to school today because he was feeling okay.  Mom reports that the dizziness is intermittent and not persistent.  She notes that it has only been a couple days and will continue to monitor him.  Informed Mom that along with the water increase, she can try increasing his salt intake over the next couple of days.  Instructed Mom to continue to monitor him and keep a log of his symptoms.  Instructed her to call the office to schedule with her doctor if symptoms persist.  Mom agreed with plan and had no other questions at this time.
DIZZY, SWEATY, ? IF PASSED OUT (HEAD DOWN ON DESK). STATING SHE DID NOT FEEL WELL. SLOW TO ANSWER.  COULD NOT FEEL OR MOVE HANDS/FINGERS, CONTRACTED AND COLD/BLUE. RESP NORMAL 12 /MIN AT FIRST.  CRYING, SHIVERING, NUMBNESS IN BOTH LEGS.  STARTED TO HYPER VENTILATE, ENC TO SLOW BREATHING.  NO H/O PANIC ATTACKS, DENIED BEING NERVOUS BEFORE SHOT.  BP 120/81.  PULSE OX= 75%.  AMBO ARRIVED.  O2 SAT= 100%.  TO ER.  HIVES ACROSS CHEST REPORTED.
Syncope episode after MENACTRA & GARDASIL vaccine given. Fell to floor from exam table. Pt with headache, nausea, fatigue, vomit x 1. Sent to ER for evaluation.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Patient stated they were nervous getting and following the vaccine. Vomiting following shortly after vaccination. Vitals were taken, fluid (water) was given and continued observation for thirty minutes.  Patient felt immediately better after vomiting.
Rash on both face and arms and hands. Rash appeared a few hours after I received vaccine.
Dizziness, Headache, Myalgia, Fever & NauseaVomiting  Narrative: Developed headache, injection site soreness and swelling, myalgias and chills. Had fever up to 104F. Febrile through 2/28/21. Lightheaded and dizzy,  requiring treatment in urgent care. Does report history of likely covid infection in 10/2020 with similar symptoms, though this was not laboratory confirmed.    Other Relevant History:
L shoulder pain with limited range of motion due to pain, L axillary lymphadenopathy, rash on dorsal aspect of both hand and inner thigh appeared on 3/28/2011 ( 3 days ) after vaccination.
2 weeks after second shot, 4/28/21. Insane cramping and bleeding during period week.  I have never experienced this before.  I have been experiencing these symptoms ever since.  Period week is TERRIBLE. I do get breakthrough bleeding during the month and cramp a lot. I am on birth control, this shouldn?t be happening
This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018; M044719, exp. date: 07-MAY-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccines were stored under temperature -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA001467.
ED to Hosp-Admission Discharged   4/29/2021 - 5/1/2021 (2 days) hospital  doctor Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary (Physician) ? ? Internal Medicine   HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Patient                                                            Date: 5/1/2021 Admission Date: 4/29/2021 Length of stay: 2 Days Discharging provider:(doctor)   Admission diagnosis:     Primary Admission Diagnosis    Medical Problems     Hospital Problems        POA    * (Principal) Pneumonia due to COVID-19 virus Yes         Hyperlipidemia Yes         Other specified hypothyroidism Yes         Nausea & vomiting Yes         2019 novel coronavirus disease (COVID-19) Yes         Hyponatremia Yes       HPI: 66-year-old female admitted with low-grade fever and abdominal discomfort.   Aminal discomfort and low-grade fever: Likely due to COVID-19 infection?initially patient was hypoxic but then her saturation was staying more than 90%.  Patient did not want to have remdesivir or convalescent plasma?she was treated with dexamethasone which she will continue for 5 more days upon discharge.   Patient had a second Covid vaccine around 4 to 5 days prior to this admission?hopefully she will have good recovery going forward and wont need any further treatment except for p.o. steroids.   Patient was able to tolerate p.o. diet at the time of discharge without any nausea vomiting.   She was advised to continue to follow-up with oncologist for ongoing treatment for her underlying cancer.   Patient was feeling well?off oxygen and expressed desire to go home on 5/1.  Thought to be medically stable for discharge?advised patient to check her oxygen level at home and come back to hospital if she has worsening shortness of breath.
Really bad low back pain in pelvic area from Oct 8 - till Nov 3. Took Ibuprofen or Acetimine for pain. Hot water bottle. Use my cane. Woke up and could hardly walk.
(I'm a FP Physician).  My daughter had the Gardisil vaccine twice, six months apart. The first time she had mild numbness and very mild weakness of her arm starting withing 5 minutes of vaccine admin. and continuing for several hours.  Otherwise she felt fine.  The second time (this time admin. with the Meningococcal vaccine), she had onset moderate numbness within 5 minutes of both her arm and leg on the affected side, and had difficulty using her arm (felt weak. No leg weakness, just numbness and some mild difficulty coordinating movements.  It was much worse than the first time she had the shot (and we won't be giving her the third shot!).  This lasted for about 2-3 hours and resolved, but was worrisome at the time. The second vaccine was about a month ago.  She's had no problems since or in-between shots.  She's very healthy and never had any problems with any vaccines before.  No fever, headache, dizziness, or other sxs assoc.  I wouldn't have reported it, but I saw the blurb about it on the FP news and thought you should know of this case too.
Lump in her arm; after having the 1st vaccine, for 2 days, her eczema went away; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Lump in her arm) and THERAPEUTIC RESPONSE UNEXPECTED (after having the 1st vaccine, for 2 days, her eczema went away) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12A21A) for COVID-19 vaccination.     The patient's past medical history included Eczema.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (Lump in her arm) and THERAPEUTIC RESPONSE UNEXPECTED (after having the 1st vaccine, for 2 days, her eczema went away). At the time of the report, PERIPHERAL SWELLING (Lump in her arm) and THERAPEUTIC RESPONSE UNEXPECTED (after having the 1st vaccine, for 2 days, her eczema went away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reports that after taking the vaccine she no longer has eczema, and has no more stuffy sinuses. Concomitant and treatment information not provided   This case was linked to MOD-2021-104857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Significant information includes: 2nd dose details given
Rash that covered whole left arm from injection site to the left hand that was extremely itchy and lasted for 3 weeks; papules; vesicles; Rash that covered whole left arm from injection site to the left hand that was extremely itchy and lasted for 3 weeks; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 (Lot number: EN6208) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "positive epstein barr virus", start date: Sep1987 (ongoing), notes: positive epstein barr virus, Pertinent details: Secondary to mononucleosis Sep1987; "Splenectomy", start date: 19Dec1999 (unspecified if ongoing), notes: Car Accident 19Dec1999. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EN6200), administration date: 19Feb2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 27Mar2021, outcome "recovered" (27Apr2021), PRURITUS (non-serious), outcome "unknown" and all described as "Rash that covered whole left arm from injection site to the left hand that was extremely itchy and lasted for 3 weeks"; PAPULE (non-serious), outcome "unknown", described as "papules"; BLISTER (non-serious), outcome "unknown", described as "vesicles". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: The patient has provide information regarding the reported adverse event (s) with the use of the product. The patient has considered the Pfizer product had a causal effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 4 year old male with a history of asthma, and no drug reactions or allergies, who on 09-DEC-2003 was vaccinated subcutaneously with 0.5mL of varicella virus vaccine live (Oka/Merck) (Lot # 643032/0593M). Concomitant therapy included Ventolin and inhaled corticosteroid (unspecified) (+) montelukast. The patient was initially examined on 21-JUN-2007 for a cough, and instructed to use his inhaler. He was examined again on 22-JUN-2007 because his arm hurt. The patient had a 1.5cm by 2 cm macular lesion on left shoulder. On 25-JUN-2007 the patient was examined and presented with a vesicular rash from shoulder to wrist. The patient did not have any other symptoms than pain. The patient was started on Zovirax for treatment of shingles. The patient was not recovered at the time of reporting. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Significant swelling around injection area.  Tenderness and elevated temperature.  Resolved in 24 hours with cold compress.
Dizzy; Veritgo; Warmth; Tingly tongue; Very sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203) via an unspecified route of administration in the right arm on 17Mar2021 at 10:30 hours (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included IBD (Inflammatory bowel disease). The patient was known allergic to penicillin.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN), juleber (MANUFACTURER UNKNOWN), immodium (MANUFACTURER UNKNOWN), tyle (MANUFACTURER UNKNOWN) within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced warmth at 05:30 hours, then tingling tongue and very sore arm. Next morning at 05:30 hours,the patient felt dizzy and vertigo. The patient did not receive any treatment for the adverse events. The clinical outcome of the events warmth, tingling tongue, very sore arm dizzy and vertigo was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Her mouth on the right side broke out in sores. She could not wear her top teeth. The sore came out on her lips upper and lower. Very painful and also on the right side of her nose. She couldn't eat. She called her doctor and her prescribed her some antibiotics and after a few days it started to heal.
CDC reports: 6 mo infant developed fever 100.6 & convulsion following DTP/OPV immunization. Pediatric DT recommended for following immunization.
Two weeks after my vaccine in the evening I broke out in hives and a rash on my legs and back. My throat got scratchy so I took Benadryl and it continued for the remainder of the day. The rash continued and I used over the counter ointments but that didn't work. January 28th I went to the doctor and she referred me to a allergist. They checked for autoimmune and everything came back normal. The doctor did say that my white blood cell count was up and he prescribed me prednisone for 10 days and Allegra twice a day. This issue is still on going and I have a follow up appointment on 4/5/21.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown demographic. On unknown dates these patients were vaccinated with improperly stored doses of GARDASIL (K011562 expiry: 08-APR-2017) (dose and route were unspecified). No adverse effect were reported. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several cases received from the same source. Additional information has been requested.
Patient developed B PE's within a week of the vaccination.  She has had a DVT before, but no other known risk factors
Pt with c/o extreme nausea and metal taste in her mouth.   Received 1000ml bolus of NS IV (11:13am).  Solu-Medrol 125mg IV (11:13am), Zofran 4mg IV (11:13am) and Compazin 10mg IV (15.44pm).
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGLES VACCINE (received on an unspecified date) and Flu vaccine (received on an unspecified date). On 18th August 2018, the patient received the 1st dose of SHINGRIX(intramuscular) .5 ml. On 18th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient's concomitant product included blood pressure medication. The patient reported that she received the SHINGRIX vaccine and experienced shivering that woke her up at night. The patient received the vaccine between 4:00 and 5:00 pm and approximately six hours later she had the shivers which resolved. The patient had denied permission to contact their physician.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. An adult female patient received PREVNAR 13 intramuscularly on the left upper arm on an unspecified date. Relevant medical history was unknown. Relevant concomitant medications were unknown. On an unspecified date, the patient experienced swelling at the site of injection and swelling on the left upper arm was more than normal. The outcome of the events, swelling at the site of injection and swelling on the left upper arm was more than normal, were unknown. The physician considered that there was a reasonable possibility that the event was related to PREVNAR 13. Follow-up (11Oct2013): Follow-up attempts completed. No further information expected.
Ulcer or Patches come and go, on different locations on the Tongue; Chills After Second Shot; Fever (Unknown Fahrenheit) After Second Shot; Second dose administered more than a month after the First; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Ulcer or Patches come and go, on different locations on the Tongue), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than a month after the First), CHILLS (Chills After Second Shot) and PYREXIA (Fever (Unknown Fahrenheit) After Second Shot) in a 27-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TONGUE ULCERATION (Ulcer or Patches come and go, on different locations on the Tongue) and CHILLS (Chills After Second Shot). In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than a month after the First) and PYREXIA (Fever (Unknown Fahrenheit) After Second Shot). The patient was treated with CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETICONE (MYLANTA [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE;SIMETICONE]) (oral) for Mouth ulcer, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Mouth ulcer, at an unspecified dose and frequency and TRIAMCINOLONE for Mouth ulcer, at an unspecified dose and frequency. In February 2021, CHILLS (Chills After Second Shot) had resolved. In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than a month after the First) and PYREXIA (Fever (Unknown Fahrenheit) After Second Shot) had resolved. At the time of the report, TONGUE ULCERATION (Ulcer or Patches come and go, on different locations on the Tongue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reported that she experienced Tongue ulceration.   This case was linked to MOD-2021-259009 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Additional information received with no significant information.
Symptoms were mild; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and VACCINATION COMPLICATION (Symptoms were mild) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION (Symptoms were mild). At the time of the report, COVID-19 (Tested positive for COVID) and VACCINATION COMPLICATION (Symptoms were mild) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: positive Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  Treatment medications included BAM Infusion used on 10 Feb 2021.   This case was linked to MOD-2021-256806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received and event outcome was updated.
uncontrollable high pitched crying for 12-18hr;starting onset 6hr p/vax large amount swelling & redness @ site of vax;
Sore right arm with throbbing moderate headache that lasted for 24 hours.  Pt took 500 mg tylenol po.
The patient was signed up for the Pfizer vaccine which we ran out of doses. The patient said they were fine with Janssen and it was switched at the out window to that vaccine. The patient was 2 months shy of his 18th birthday which Janssen is not indicated for. The patient had no adverse reactions to this point but we wanted it documented.
generalized body aches for 2 weeks. residual left knee and hip pain that is chronic but worse than her normal. this is now improving.
Did not take third dose of Vivotif for 4 days after taking the second dose; Spontaneous case was received on 30MAR2020.  A physician reported that male consumer who "did not take third dose of Vivotif for 4 days after taking the second dose" (PT: Product dose omission). He was receiving Vivotif for immunization. The consumer took the first and the second dose of Vivotif according to schedule but, did not take the third dose for 4 days after taking the second dose. The reporter did not know the exact dates of the doses but guessed he took the first two doses on 24MAR2020 and 26MAR2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome was unknown.  Company Comment: A consumer missed taking third dose of vivotif (missed dose). Vivotif should be taken every other day and the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed taking third dose of vivotif (missed dose). Vivotif should be taken every other day and the causality of missed dose is assessed as not applicable to Vivotif.
Well it started with severe chest pains, I had to go to the ER. I was diagnosed with pericarditis and inflammation in the kidneys. I was going into kidney failure. It took 2 months to come up with diagnosis. I had to have a kidney biopsy.
Patient received second dose of vaccination today. Patient sitting in monitoring area and called for nursing attention. Patient reported that she felt faint and anxious after receiving vaccine. During assessment, patient reported she had fasted for blood work this morning and only had coffee and a snack of nuts. Offered patient Gatorade and nutrition bar. Patient reported nausea and still feeling dizzy after eating. Patient requested nursing to keep an eye out for her. Patient refused to lay down and rest and initially refused Medic assessment. Patient agreed to stay in monitoring area since she was sitting alone and came alone to the vaccine site. Patient stated that she was ?just nervous? and that she felt her ?chest got tight? but non-radiating. MD consult and Medics called to assess patient for concerns.
pt recv 3rd dose of vax 29DEC95;Nurse  thought was administering chicken pox vax;hlth provider was not familiar w/the booster interval;pt stated had some soreness @ the inj site w/no redness or swelling p/vax;