chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of M-M-R II, (lot#L012482 and expiry date 10-APR-2017) subcutaneously (strength, dosing details, anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. This is one of the 3 reports received from the reporter source. Additional information has been requested.
sudden loss of vision in the eye on 11/20/21 , Diagnosed with Chorioretinitis OS, unclear etiology, complicated by macular neovascularization, it happened  2 days after  her booster shot Pfizer vaccine She has been on high-dose prednisone since and now at 10 mg daily dose, plans to cut down to 5 mg daily from this week has persistent partial vision loss
This spontaneous report as received from a medical assistant refers to a 14 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M004328, expiration date: 26-JAN-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
The staff had the Covid vaccine in the morning 12/23/2020.  In the afternoon, received a phone call from her boss saying that her boss was COVID positive. Boss only had headaches.  Then the staff went to have Covid test, the result was negative.  On Thursday she started to expreience headache, still having headache and mild body ache.
Dizziness and urticaria pruritus. Diphenhydramine 50 mg once.
Beginning at 2:10 am on 3/31, right arm from shoulder to fingertips was in acute pain for 2 hours then pain reduced for 1 hour and then acute pain repeated for 2 more hours from below the shoulder to the palm of the hand.  Pain eased for 1 hour then acute pain repeated for 2 hours from mid-bicep to mid forearm.  Pain eased for 1 hour then acute pain repeated for 2 hours from 3 inches above the elbow to 3 inches below the elbow.  The left shoulder area has continued to be sore for 11 days and the entire right arm has been sore for 11 days.
Began feeling dizzy and weak within one hour of vaccinations; Had flu-like symptoms within 48 hours with fever, weakness and profound fatigue. Continued weakness for one week with follow up visit completed physicians office. Continues to have weakness and fatigue.
Pt. developed cellulitis at the site of injection 4-20-13 on the arm. Pt went to clinic on 4-21-13. Dx - cellulitis pt started on BACTRIM DS.
P/S approx 4 hours post vacc. administration L upper arm tricep area became sore, reddened, and hot to touch states temp on 6/12/02 102.8, tx antibiotic in hosp. IV and PO.
Temp 102.8 3AM decreased 101 after Acetaminophen mild SOB continued throughout next day body aching (Ribs).
very weak; hot and cold; fever 100.1; extreme chills; could not get out of bed; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills) and FATIGUE (could not get out of bed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042l20al) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (very weak), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills), FATIGUE (could not get out of bed) and NAUSEA (nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (hot and cold), PYREXIA (fever 100.1), CHILLS (extreme chills) and NAUSEA (nauseated) had resolved. On 05-Mar-2021, ASTHENIA (very weak) and FATIGUE (could not get out of bed) had resolved.
Patient had swelling, fluid accumulation, and redness near her elbow in the right arm. The pain, swelling, and redness was distal from the injection site. The adverse effects were resolving on their own at the time of reporting without treatment.
Information has been received from a 62 year old male with leukaemia and a history of allergic reaction to LEVAQUIN who on 13-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included omeprazole (MSD).  Subsequently the patient experienced rash and itchiness on his back and leg.  The patient's rash and itchiness on his back and leg persisted.  Medical attention was not sought.  There was no product quality complaint involved.  No further information is available.
No additional AR reported; third dose of GARDASIL 9 on Nov 4, 2022; Nurse stated that patient received the first dose of GARDASIL 9 on Aug 5, 2019, second dose of GARDASIL 9 on Sep 23, 2022 and third dose of GARDASIL 9 on Nov 4, 2022. No further information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from Other Health Professional and refers to a female of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-AUG-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 23-SEP-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, second dose, lot #T036444, expiration date: 09-APR-2023, administered for prophylaxis (strength, and route of administration were not provided). On 04-NOV-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, third dose, lot #T039466, expiration date: 20-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided).  On unknown date, nurse stated that patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 05-AUG-2019, second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 23-SEP-2022 and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 04-NOV-2022 (Inappropriate schedule of vaccine administered). No further information provided. No additional AE reported. No PQC reported.
A 15 year old male pt experienced mid-sternal chest pain, musculoskeletal pain and myalgia while rreceiving RabAvet. The pt received 1ml of RabAvert IM on 3/10/03 for a stray cat bite, on a post-exposure basis. The pt had received 2 doses at the time of the report and was still on treatment. He developed mid-sternal chest pain, musculoskeletal pain and myalgia following the first dose, and was evaluated in the ER for these complaints. No interruption of the drug therapy occurred. The physician determined that the events were possibly related to the RabAvert.
Parotitis, fever on 6SEP91 lt parotid gland swelling on 8SEP91;
measles - like rash on face cheeks and between eyebrows (worse on right side); Throat and tongue swelling; Throat and tongue swelling; headache; sore arm; dry and flaky skin; dry and flaky skin; swollen red itchy and painful oval and circular red bumps; Swollen neck lymph nodes; This is a spontaneous report from a contactable consumer (patient).  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0182) via an unspecified route of administration at arm left on 16May2021 11:00 A.M. (at the age of 45-years-old) as DOSE 2, SINGLE and first dose via an unspecified route of administration at arm left on 25Apr2021 at 11:00 A.M. (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for covid-19 immunisation. The relevant medical history included multiple sclerosis. The prior vaccinations within 4 weeks were reported as none. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Concomitant medications included baclofen, valaciclovir (VALACYCLOVIR), fampridine (AMPYRA), gabapentin and dextromethorphan hydrobromide monohydrate, quinidine sulfate dihydrate (NUEDEXTA); all from an unspecified date for an unspecified indication. Past drug history included allergies to morphine, codeine and gadolinium. On 27Apr2021 at 12: 00 P.M, the patient experienced throat and tongue swelling, swollen neck lymph nodes, headache, sore arm, measles - like rash on face cheeks and between eyebrows (worse on right side) characterized by swollen red itchy and painful oval and circular red bumps, dry and flaky skin. The patient underwent doctor or other healthcare professional office/clinic visit for claimed events. Therapeutic measures were taken as a result of events included diphenhydramine (BENADRYL), topical corticosteroids, ibuprofen, ice. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse, for the pregnancy registry for GARDASIL, concerning a 17 year old female with allergy to Amoxicillin and Codeine and no relevant medical history who on 03-Mar-2008 was vaccinated intramuscularly with a first 0.5ml  dose of GARDASIL (lot number 659441/1446U) (injection site not reported). On 02-Jun-2008 and 08-Sep-2008, the patient was vaccinated intramuscularly with a second and third 0.5ml dose of GARDASIL (lot number 660387/1967U) (injection site not reported). Concomitant therapy included NUVARING. Subsequently the patient was pregnant. Her LMP was 23-Aug-2008. On 22-Sep-2008 the patient had a low grade PAP smear. The patient went to the physician's office. Laboratory tests included ultrasound and blood work (results unspecified). The outcome of the patient's experience was unknown. Additional information has been requested.
cried 4 hr straight, 2 days p/vax given; very irritable, vomited x 1; fever of 101;
Patient received vaccine after published expiration date inadvertently. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity needed to protect against covid 19 on date vaccine was administered. Also patient did not call in complain of adverse event.  This is administrative error without adverse event.
Systemic: Other- 2 hours after vaccination patient complained of feeling unwell,blood pressure check 193/102.911 called and pt transported to er
She states she is having the side effects of feeling unwell; tired; blood pressure elevated; some chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), 15 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer.), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She states she is having the side effects of feeling unwell"; FATIGUE (non-serious), outcome "unknown", described as "tired"; HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure elevated"; CHILLS (non-serious), outcome "unknown", described as "some chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Dose/Dosage Form was Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal 12 years - 15/15 mcg per dose. Patient had received Booster dose yesterday of Pfizer COVID 19 Bivalent vaccines and had the side effects of feeling unwell, tired, blood pressure elevated, some chills. Consumer stated that she knows these are normal side effects according to the information they gave and asked how long will the side effects to last? What patient can take for the side effects?  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Headache, Myalgia, Fever, SkinRash, Rash,  Lethargy Narrative:  Other Relevant History:
Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath,  Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain
pt recvd vax 27JUN95 & 6JUL95 pt devel conjunctivitis & persistent diffuse erythematous vesicular rash in patches that looked like shingles x/not in clusters & was sl itchy
1.  Back of throat very dry-immediately after shot was given-lasting 1hr 2.  Lips became slightly numb -immediately after shot was given-lasting 1hr
burning nerve pain in her left arm, left shoulder, and her chest/neurological symptoms; A spontaneous report was received from a physician (reporting on self) concerning a 38-year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced burning nerve pain in her left arm, left shoulder, and her chest/neurological symptoms (neuralgia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 037K20A) Intramuscular, in her left arm for the prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient experienced neurological symptoms on the side where she got the injection.  It felt like a burning nerve pain on her left arm, left shoulder, and chest.  On 06 Jan 2021, the patient was treated with Motrin (Ibuprofen).  Action taken with mRNA-1273 in response to the event was not reported.  Outcome of the event of burning nerve pain in her left arm, left shoulder, and her chest/neurological symptoms (neuralgia) was not recovered.; Reporter'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.
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 25-OCT-2012 20:24, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
If the person giving me the shot, pushed the medicine in slowly instead at lightening speed, would my sore arm feel better?; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient received shingrix vaccine and experienced sore arm. The patient wanted to know if the person who gave the vaccine shot, pushed the medicine in slowly instead at lightening speed, would the sore arm  would have been feel better. No other information was reported.
pt recv vax 17JUL97 & onset of extreme lethargy, lightheadedness gen myalgias 21JUL97;noted gen papular rash over back, abd arms, legs, scalp w/severe pruritus 28JUL97;c/o feeling warm & noted presence  tender posterior cervical nodes 26JUL
This spontaneous report as received from a female consumer of unknown age referring to herself. The patient's medical history included prior case of shingles. None drug reactions or allergies were reported. On an unknown date in 2006 the patient was vaccinated with ZOSTAVAX, subcutaneous injection, 1 single shot, (dose, dose number, anatomical location, expiration date and lot number were unspecified). Concomitant therapies included an unspecified heart medication. On an unknown date the patient experienced that she has had 3 shingles outbreaks since ZOSTAVX vaccination. None laboratory diagnostic studies were performed. The patient sought medical attention (unspecified). The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
15MAY91 105 fever, lethargy, sleepy for 36hrs starting 8hrs p/inject;
Patient reports feeling normal the day receiving vaccine. However, woke up the next morning and was sore all over -- said muscles and joints felt sore. She reported symptoms progressing throughout day 2 and by the end of the day, husband had to pick her up out of bed and bring her to the restroom and back. Patient reports not being able to walk at all. Patient reports feeling really sore Thursday upon awakening, but was able to move at this time. Symptoms improved through the day and patient reports full recovery at this time.
10 months since 1st vaccine, should I start over; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose 10 months prior to the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 3-Feb-2023 Reporter's comment: The patient asked that what if it had been 10 months since his/her first Shingrix vaccine, he/she should start over with the first one again. The patient was asking for someone else and just want a direction. The representative stated that please note that GlaxoSmithKline had not done any studies on the Shingrix second dose beyond six months from the first dose. However, center of drug control and prevention (CDC) had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients did not need to restart the vaccine series. If your second Shingrix vaccine was later than six months after receiving the first Shingrix vaccine, please consult with your healthcare provider about guidance and your individual situation. Because patient care was individualized, a healthcare provider should always be consulted to evaluate your health and provide guidance to you based on your medical history. They as a pharmaceutical manufacturer, did not provide medical advice or guidance. If your healthcare provider needs additional information about their medications, they may contact the GlaxoSmithKline medical information department. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Pt called stating she has had pain in the hips and legs, restless legs, difficulty sleeping, sinus congestion and runny nose, fever of 101.7F, since around midnight of 12/3/22 after receiving her Moderna booster.
When she scratches the rash, it results to bleeding; Hives (not in patches but randomly all over leg and arm)/Rash and hives all over; Itching; Rash; This is a spontaneous report received from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- ER8729) via an unspecified route of administration in right arm on 27Jul2021 14:30 as dose 1, single (at the age of 44-years-old) for COVID-19 immunization. Vaccination facility type was reported as Clinic. The COVID-19 vaccine was administered to patient in military facility. Patient medical history included ongoing type 2 diabetes mellitus and ongoing hypothyroidism both of which were diagnosed 5 years ago. The concomitant medications included metformin,  strength 1000 mg, taken for type 2 diabetes mellitus (Type II Diabetes) at a dose and frequency of 1000 mg, 2x/day with a daily dosing of 2000 mg from an unspecified start date and ongoing. The patient experienced when she scratched the rash, it resulted to bleeding, hives, itching and rash on 27Jul2021 19:00/20:00. Event onset dates for rash and hives all over was 27Jul2021. The event seriousness was reported to be unspecified. She clarified it was the COVID Vaccine. She stated was wondering if there was anything reported about a rash, hives all over. She got the shot yesterday. She got the shot about 14:30. The rash and hives started yesterday evening. By 19:00/20:00, patient legs were itching like rash and hives and it gradually went up to her knees and back of her legs. The rash and hives were like random spots. Then last night it started moving on her arms. Patient stated that she was taking Benadryl to keep from scratching skin off. She confirmed that she took her first dose of vaccine. While attempting to capture details, caller started speaking to someone in the background and difficult to hear/understand conversation with individual in background. Patient then came back to line and stated that her youngest son was mentioning about his own itching issue after receiving the COVID vaccine. She commented her vaccination card has the lot details, but the other ones do not. The adverse events did not result in physician or emergency room visit. Therapeutic measures were taken as a result of when she scratches the rash it results to bleeding, hives and itching. The outcome of the events was not recovered.  Follow up (28Jul2021): This is a follow up spontaneous report received from a contactable consumer or other non-HCP (patient herself) and included event onset date details, unspecified reporter seriousness, adverse event details, confirmation on her vaccine dose number, information that the COVID-19 vaccine was administered at a military facility, prior vaccination details and details that the adverse events did not result in physician office or emergency room visit as was merged and processed with the initial narrative.