chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant referring a 5 year old female patient. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On 14-JAN-2016, the patient was vaccinated with M-M-R II, subcutaneously, for prophylaxis (dose, lot number and expiration date were not reported). On the same date, he also was vaccinate with VARIVAX, subcutaneously, for prophylaxis (dose, lot number and expiration date were not reported); and KINRIX, for an unknown indication (dose, frequency, route of administration, lot number and expiration date were not reported). On 10-APR-2017, the patient inadvertently was vaccinate with a second set of booster doses (extra dose administered) of M-M-R II (lot # M044351, expiration date 04-NOV-2018), subcutaneously, for prophylaxis (dose not reported); and VARIVAX (lot# M042496, expiration date 19-OCT-2018), subcutaneously, for prophylaxis (dose not reported). The patient did not seek medical attention. At the time of reporting, no adverse effects had been reported as of yet. No further information provided. No product quality complaint was involved. Additional information has been requested.
pt to ED and was hospitalized from 7/16-7/22/22 at the Hospital for SOB requiring O2 supplementation; tested positive for COVID; given Remdesivir and Decadron; O2 needs increased; pt's condition worsened; pt was transitioned to DNR/DNI; pt dc'd to hospice facility where she passed away
Fever of 103 for 72 hours, severe sore throat and cough lasting more than a week, nausea.
Admitted with history of covid, 1/8, now with severe constipation and colitis (admitted WITH hx of covid, not FOR Covid).
Arm is still a little red; Arm is still a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR176120).   In July 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced erythema of extremities and pain in arm. On an unknown date, the outcome of the erythema of extremities and pain in arm were not recovered/not resolved.  It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine about a month ago from reporting date and his/her arm was still a little red and sore. This is 1 of 3 cases reported by the same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176120:Same reporter US-GLAXOSMITHKLINE-US2021AMR176129:Same reporter
45 yo female received varicella vax. Developed 14"x14" Rash, high fever and infection to injection area.
Information has been received from a health professional concerning a 5 year old male who on 6/13/97 was vaccinated with 1 dose of varicella virus vaccine live (site unk). Subsequently, it was reported that on 6/20/01, the pt was dx'd with "a very mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
08/15/21- outbreak of hives - treated with antihistamine  08/28/21-Urgent care visit to take care of bad hives and evaluate 09/23/21-Dermatologist visit, prescribed antihistamines 12/11/21-ER visit to take care of bad hives, antihistamines no longer effective 12/16/21-Dr. Allergy department started prednisone, test allergies and Check TSH, antithyroid antibodies, serum tryptase  -  01/14/2022-Dr. Endocrynologist- diagnosis of Hashimoto's disease - start levothyroxine 03/23/21- Started Xolair for hives- proved inneffaective and stopped in June 06/33/21- Started Cylosporine - Could not tolerate, increased blood pressure
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The vaccine was administered in the left arm. The reporter indicated that her husband received the SHINGIRX vaccine sometime at the end of April or early May, 2018.  He experienced a sore arm that lasted for a day or two. The patient had denied permission to contact their physician.
Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks post administration, range of motion is still decreased and weakness in that arm. Patient referred to specialized medicine.
Back pain lung pain then rash so i went to doctors, and she explain I got shingles.
Warm to touch. Swellings, redness 7.5 cm long 5.2 cm wide.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Extreme headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extreme headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Fall and Rib fracture. Concurrent medical conditions included Rib pain (He took a fall and had broken rib recently, and has been taking Tylenol Excedrin and Tylenol #3 for his pain for his rib and his back) and Back pain (He took a fall and had broken rib recently, and has been taking Tylenol Excedrin and Tylenol #3 for his pain for his rib and his back).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (Extreme headache). At the time of the report, HEADACHE (Extreme headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication details reported by the reporter. Treatment medication included Tylenol (paracetamol) Excedrin (aspirin/paracetamol/caffeine); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Diarrhea and low grade fever - Patient was seen in the  office on 1/16/21. Provider stated that since the  diarrhea had become less frequent nothing needed done  at the time and noted that if the diarrhea became  more frequent or worse a culture would be ordered.
1st  Moderna Dose- Patient was given 0.25 mL instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (1st  Moderna Dose- Patient was given 0.25 mL instead of 0.5 mL) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced ACCIDENTAL UNDERDOSE (1st  Moderna Dose- Patient was given 0.25 mL instead of 0.5 mL). At the time of the report, ACCIDENTAL UNDERDOSE (1st  Moderna Dose- Patient was given 0.25 mL instead of 0.5 mL) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the dose was administered exactly 28 days from today (31Mar2022). No treatment medication was reported.
Initial information received on 12-Oct-2018 and additional information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA286240, 2018SA286241, 2018SA286245, 2018SA286243, 2018SA286244 This case is for patient number: 01 This case involves a female patient (age unknown) who experienced vaccination site inflammation, while she received vaccine FLUZONE. The patient's past medical history was not provided. No concomitant medications were taken. On 09-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AA. On an unknown date, 48 hours post vaccination, the patient developed significant local redness and swelling that warm to the touch and the location of reaction was right below the injection. It was reported that 7 of the 10 individuals who received the vaccine had significant local reactions of redness, swelling, warm to touch, As of today 3 days post vaccine all are showing signs of improvement. two days after injection seemed to be the most significant time frame for peak reaction. (Other relevant tests included no lab data.) Final diagnosis was vaccination site inflammation. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for vaccination site inflammation. Follow-up information was received from a Pharmacist on 15-Oct-2018. No new information was reported.
PT CRANKY NEXT 48 HRS AFTER IMMUN. BECAME LIMP AFTER 48 HRS. 3 EPISODES IN 3-4 HRS;MOTHER THOUGHT PT STOPPED BREATHING-NO COLOR CHANGE, NO SEIZURES, HOSPITALIZED-ABNORMAL PNEUMOGRAM. PT IMPROVED
Full body rash, red bumps, skin swells all over the full body,  full arms, full legs and feet, butts, chest. Itchy but not painful.  First Treated with two 24-hr Allegra per say plus Benadryl every 4 hours and Clobetasol Propionate cream for 3 days. No improvements. Added prednisone treatment on the 4th day  for 12 days.
Mom called office to state injection site was red and swollen. No difficulty breathing and no fever.  Mom advised to apply cold compress and to alternate Motrin and Tylenol for pain/swelling. Mom instructed to monitor the injection site and come to office if s/s worsen.  She came to office today (2/5/14) site was 1 3/4 x 1 3/4 red, raised, warm to touch, no fever, no vomiting, no difficulty breathing. Dr. looked at site and pt was advised to keep up with cold compresses and Motrin/Tylenol and to call the office or go to ER if S/S worsen.
Lightheaded; Felt a tightness in her chest; Horrible chest pain; Feeling completely out of it and confused; Feeling completely out of it and confused; Horrible headache; This is a spontaneous report from a contactable consumer or other non-health care professional(patient).  A 25-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8735) via an unspecified route of administration in left arm on 12May2021 at 15:15 (at the age at vaccination of 25-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient's medical history included ongoing migraine headaches, started a year to a year and a half ago, but it was rare if she gets one. She had not had a migraine in a while, not since she gave birth and had that. The patient's concomitant medications were not reported. On 12May2021, the patient experienced horrible headache, lightheaded (at 21:00), horrible chest pain, felt a tightness in her chest and feeling completely out of it and confused. It was reported that on 12May2021 (also reported as yesterday) an hour to an hour and a half later (also reported as between 16:30-17:00), patient experienced horrible headache. It was getting worse and was to the point she was feeling out of it. Around at 12:00 (on 12May2021), she went to take a warm, not cold shower to relax her body and she started feeling really lightheaded, that continued on 13May2021 (also reported as today), it was on and off and was felt about the same and was just there. When she was out of the shower, she went to lay down. She fell asleep for 5 minutes or so and felt a tightness in her chest. It got to the point, she would sleep 1 to 1 and a half to 2 hours. It continued on and off. It first she thought she was having an anxiety attack, if it matters, it made her feel she was out of it because it was with light headedness and stuff like that. Patient also experienced horrible chest pain, feeling completely out of it and confused. That came with the chest pain and light headedness. She had an episode 20 minutes or so before the call. It started on 12May2021 (reported as yesterday). She laid on the couch and propped herself up. She thought it would help a little bit, but it did not, and she went to lay in her bed. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Adverse events did not require emergency room or physician office visit. Prior vaccination within 4 weeks was noted as no. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
laryngospasm devel w/in 5 mins of inject manifested by dyspnea, nausea, pallor; no LOC, BP remained stable; recovered immed p/Epi, followed by DPH;
'Crushing' headache, pain going up left side of neck to temple, and left side of chest feeling painful, around heart? area, arm slightly sore and swollen, diarrhea w/bloody & tan colored mucus, urine very 'rust' colored, area above ankles initially felt constructed but lasted only that day, started taking acetaminophen when reached home after shot, took 1, then 11 hrs later another, then 11 hrs later, another. Feeling better, but crushing headache still present. Haven't eaten since shot and perusing diarrhea. Hadn't eaten that day.
1) 4/9- minor ear infection got a lot worse,  got on antibiotics immediately on 4/9 (urgent care). 4/9-4/11 ear infection continued to get worse even on antibiotics; 4/12 got on stronger antibiotics ciprofloxacin (urgent care) after  ear turned purple, absessed swollen, shooting ear pain intermittent 6-7 on pain scale, crusty red started to block ear canal; 4/13-4/15 on stronger antibiotics, symptoms got better, got worse again 4/16- 4/18; 4/18  got on stronger antibiotics again- amoxocillin (urgent care); 4/19-4/20- developed Bells Palsy on left side of face (same side as ear infection and vaccine administered on left arm) diagnosed at ER on 4/20 for Bells Palsy. On steroids, antiviral and amoxocillin antibiotics and ear ointment still and hope Bells Palsy goes away and I recover TBD- today is 4/21/21.
Reported by mother - patient not seen. Hives all over a little more than 24 hours after vaccine given. Treated with Benadryl.
Patient reports significant swelling at injection site with some pain/sensitivity which began approximatley  1 - 2 days after vaccination
Initial information received on 05 January 2010 from a health care professional. A 47 year old female patient with a history of COPD, asthma, HTN, hypothyroidism, anxiety, hypokalemia developed a metallic taste and dizziness with head movement after receiving H1N1 (lot number UP078AA) in the left deltoid on 05 January 2010. Concomitant therapy included Albuterol, "ADVIR", SINGULAIR, SPIRIVA, SYNTHROID, theophylline, MUCINEX, PROAIR, potassium, hydrochlorothiazide, "NEFOCAL XL", "DOXIPRIM", lorazepam. The reporter stated that the patient was to be "possibly" evaluated by a physician. Recovery status was unknown. No further information was provided. Follow-up information was received on 16 February 2010 from a healthcare professional. The previously reported events or metallic taste and dizziness with head movement had an onset of 5 minutes post vaccination. The patient had no illness at the time of the vaccination and had no other vaccinations within the four weeks prior. Her concomitant medications were verified: "NEFOCAL XL" was NIFEDICAL XL, "DOXIPRIM" was Doxipen and "ADVIR" was ADVAIR. The patient was evaluated by physician and the reporter stated "all" within normal limits. The patient recovered without adverse effects after several hours and without treatment. List of Documents held by Sender: none.
Three migraines with Aura in less than a year.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2021 (Lot number: FE3590) at the age of 72 years as dose 1, single and administered in arm right, administration date 04Feb2021 (Lot number: En5318) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 29Jan2021, outcome "unknown", described as "Three migraines  with Aura in less than a year.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of migraine. No follow-up attempts are possible. No further information is expected.  Additional Information: Three migraines with Aura in less than a year. Excedrin immediately at onset of aura. Patient did not provide information regarding the reported adverse event(s) with the use of the product. Administration date was 14Jan2021 of Dose number 3,Vaccine location was Right arm.If other vaccine in four weeks was Unknown. Other medications in two weeks were taken. Adverse event treatment was Excedrin immediately at onset of aura.covid prior vaccination was no.covid tested post vaccination was yes.Covid test type post vaccination was Nasal Swab. Patient had no Known allergies.Other medical history: Hypertension, arthritis, type 2 diabetes.Updated information included: Reporter slider unchecked. The patient did not provide information regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible. No further information is expected.
I felt muscle aches and pains  about 6-8 hours after I received the vaccine. I had COVID-19 in late January 2021, and these symptoms from the vaccine felt about the same as the COVID symptoms I had, they just didn't last as long. However, around 36 hours after I received my vaccine, my armpit area started to become sore. It has felt swollen and sore for the past 36-48 hours. I also developed a fever of around 100.5 degrees Fahrenheit today, so around 72 hours after I received the vaccine. I have also been fatigued for the past 3 days.
Injection site pain was immediate and continued for 12 hours at a very strong level, from 12 to 20 hours, the pain gradually subsided. General fatigue began within about 30 minutes of the injection and continued for approximately 30 hours.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored GARDASIL 9 (lot# R009614, expiration date: 30-NOV-2020, strength, dose, frequency and route were unknown) for prophylaxis. The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes. Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Returned to Vaccine Clinic approx. 60 minutes post vaccination with generalized itching, hive-like rash on chest, arms, and legs and "mild" lip swelling.  VS normal and stable during clinic observation.  O2 Sat at 100%.  Evaluated by onsite physician.  Received total of 5omg diphenhydramine during observation.  D/C'd in 2 hrs with less itching and resolving rash.  Accompanied and driven home by friend.  Spoke with EH nurse on 12/24/2020 and stated additional 50 mg diphenhydramine at home 12/23/2020.  Mild, fading rash today.  PLAN: will be evaluated by Allergy Clinic and if cleared, will receive 2nd dose of vaccine in Allergy Clinic.
Patient received her 2nd Varivax on 7/27/09.  Mother call on 7/29/09 to report that a red area the size of a ping pong ball had developed.  Tx was for Tylenol or Ibuprofen as needed for pain, ice to site and Benadryl.
Pt complained of her arm (in which she was immunized) being swollen, hot, red, and is developing a black/blue mark. Had a severe headache and difficulty lifting her arm.