chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at the injection site  initially, then shooting up my neck towards my head on the left side of my neck.  I took  400mgTylenol and went to bed. Then about midnight, awoke to sever aches and chills and an overall feeling of illness.  I could not get comfortable and could not sleep.  I was FREEZING and ACHING terribly.  I also felt nauseous but did not vomit.  I drank some white soda and ate a cracker and took some more Tylenol, again 400 mg, and went back to bed..  I took my hypertension pill as well.  I slept this time for 4 hours.  I woke up again and felt extremely weak, achy and cold.  I had zero appetite.  I drank an orange soda, took another 400 mg of Tylenol.  I went back to bed and slept for  another 4 hours.  I woke up feeling like a truck ran me over.  I sat up and watched a clip on the news about the Moderna shot adversely affecting women more than men.  I knew how bad I felt and wished I had not taken the shot.  I took another dose of Tylenol 400mg.  I was up for an hour or so and then went back to bed, sleeping until 6:00 a.m. the following morning.   I was feeling better the next day, not 100% but way better.  I was able to eat.  I took it easy  the rest of the weekend.
Patient developed redness & swelling at the inj. site. She went to the ER on 5/18/11 due to pain in the area of inj. Pt. put on BACTRIM for suspected cellulitis.
Was given the vaccine around 9:40 am on 10/12/2021 and around 2 pm on the same date patient started to have dizziness and ended up falling. This episode lasted ~10 min and then patient felt normal again. No other issues were reported
Information has been received from a physician concerning an 11 yr old male with no pertinent medical history and no drug reactions/allergies who on 17Jun96 was vaccinated with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. Subsequently the pt developed a mild case of shingles. Unspecified medical attention was sought. Subsequently, the pt recovered. There were no laboratory diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
The day after injection, a large red, raised bump appeared at the injection site. It was approximately  2 inches in diameter and the height of a quarter. It was very itchy, but not warm to touch. 4 days after injection the swelling went down and it faded into a bruise. No other noticeable symptoms were present.
Recieved first hep b shot and IPV shot on the morning of August 20, 2009.  By 11pm had high fever that lasted until August 22.  Also had muscle aches, loss of appetite, disorientation, and tireness.
The night following the J&J vaccine (taken at 2:00 pm), I had a high fever.  The following day, I felt sharp chest/back pains and experienced difficulty breathing laying on my back. This persisted for about 24 hours.
CHEST TIGHTNESS; MUSCLE SORENESS; SMALL HEADACHE; NAUSEA; COLD CHILLS; FEVER; This spontaneous report received from a patient concerned an adult of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chest tightness. On MAR-2021, the subject experienced muscle soreness. On MAR-2021, the subject experienced small headache. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced cold chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle soreness, small headache, nausea, cold chills, fever and chest tightness was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Within 2 weeks of administered expired vaccine, severe headache onset. Frequent headaches since. No severe headaches prior to vaccine.
Tightness in chest; Sore throat; Fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp. A 27-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Mar2021 16:45 (age at vaccination: 27-Years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient didn't had COVID-19 prior to vaccination. Patient didn't other vaccines within 4 weeks prior to vaccination, patient had received other medication was Daily multivitamin within 2weeks of vaccination. The patient medical history and concomitant medications were not reported. On 13Mar2021 18:00 the patient experienced tightness in chest, sore throat, fatigue. No therapeutic measures were taken for the events. Patient was not tested with COVID-19 to post vaccination. The outcome of the events chest discomfort, oropharyngeal pain, fatigue was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Fever; Diarrhea; This is a spontaneous report from a contactable physician reporting for a male patient (husband) via Pfizer Employee. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Basically the patient is a physician, up in that area he was able to get the vaccine shot, the COVID vaccine shot and he got it recently, the reporter didn't tell the date, but just said recently. The patient did have some pretty severe reactions, he had like fever and diarrhea for a couple of days. In the reporter's medical opinion she felt and in her husband's medical opinion he is a physician also, they felt it was from the vaccine these adverse events were caused from the vaccine in their opinion. The events had resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Five days post vax the pt developed generalized chickenpox with fever of 102.6F. It was indicated that the pt had approximately 50 lesions covering her entire body, but mostly on her head and torso. Subsequently the pt recovered from symptoms. The reporter expressed concern with the vaccine lot. No further information is available.
Mild, itchy rash on face and trunk; some red macules and other tiny pustules c/w mild vaccinia. Recovered in 48 hours.
Headache and arm pain began at 11:30pm. Then I woke up at 2:30am with chills, fatigue, nausea, body aches, and congestion
developed shingles/ suspected vaccination failure; developed shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 58160082311) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 58160082311) for prophylaxis.   On 08-JUL-2020, the patient received the 2nd dose of Shingrix. On 12-FEB-2020, the patient received the 1st dose of Shingrix. On 29-OCT-2023, 1208 days after receiving Shingrix and 1355 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: developed shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 06-NOV-2023 The reporter was a caregiver. The patient had the Shingrix vial kit. The symptoms were treated. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The reporter consent to follow up.
On March 15, 2021, you can down mild virial like symptoms, you became fatigue, and started having mild dizziness, mild confusion, ringing in both ears, right ear was worse than the left and my neck glandes were swollen, at that point I schedule in person visit with my doctor. My doctor visit was on Tuesday, March 23, 2021, at 9am, they took a look at my neck glandes and ears, my eardrums fine and it looked like a viral infection, so they ran a blood panel results showed a little elevated liver enzyme. They did not order a covid-19 test. I had a follow up appointment on or around May 6th, 2021. They did more blood work to see if my liver enzymes went down, which they did and then they ran a Lyme dieses test, hepatitis test. Mononucleosis test, all came back negative. My fatigueless and brain fog continued.
Information has been received from a physician concerning a 12 month old male who on 06-APR-2006 was vaccinated with a dose of Varivax. On 16-APR-2006, the patient developed a fever and a maculopapular rash. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Congested/stuffy nose; not feeling well; Pressure in the head; Runny nose; a bit of a head cold; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534; Expiration Date: 31Jul2021, NDC number: Unknown), via an unspecified route of administration, administered in left arm on 19Mar2021 at 13:30 (at the age of 53-year-old) at single dose for Preventive Care. Medical history included anxiety. Concomitant medications included sertraline taken for anxiety from 2021 (reported as started taking about a week and a half ago to two weeks before 09Apr2021) and ongoing, he also took vitamins but didn't think vitamin c and vitamin d were going to make the list. Patient reported that he was due for second dose of Pfizer BioNTech Covid 19 vaccine on 09Apr2021 but last night (08Apr2021) and this morning (09Apr2021) had a bit of a head cold, and pressure in the head. Patient couldn't make his second dose today (09Apr2021) because he was not feeling well. He was experiencing head cold symptoms now. Patient stated that his runny nose started last night (08Apr2021) around 2100 or 2200 and then he woke up today (09Apr2021) with congestion and a stuffy nose. Patient stated he had not taken anything for it. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect additional administered vaccines and no prior vaccinations (within 4 weeks). Events were not required a visit to Emergency Room nor Physician Office. No family medical history relevant to AE. No Investigation Assessment and Relevant Tests. No treatment was received for the events. The outcome of the events congested/stuffy nose and runny nose was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
2 days P vaccine pt called in complaining of loss of leg ins-  Flu T PCP/ post vaste
This spontaneous report was received on 01-MAY-2017 from a pharmacist and refers to a 14 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, when the patient was 12 years old, they received the first dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not reported). On an unknown date, when the patient was 14 years old, they were vaccinated with the second dose of GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not reported). No adverse effect reported. No additional information was provided. Additional information has been requested.
This was my second shot, Hives all over the body. Mostly on the arms and legs. Nothing at the injection site. The hives did not start until 22 hours after receiving the vaccine. No reaction from 1st shot.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 HTN (HYPERTENSION)
Sudden onset of systemic itchy skin with raised wheals and dermatographia after scratching.  Raised wheals and redness subsides approximately one hour after scratching, but systemic itchiness persists and wheals and dermatographia symptoms return after scratching again.
Shot rec'd 6-5-08.  Within 5 min: burning; within 15 min: itching; within one hour: swelling.  Within 3 hours - enlarged (1 1/2" x 2 1/2") bright red area at injection site with a lighter discolored area extending (4") down arm toward the elbow.  12 hours: no burning, but swollen, red, itching.  6-11-08 (6 days later) still swollen & red, very little itch.  6-14-08: no swelling or itching, but still red.
Pt was given Pediatric Influenza Sanofi Pasteur 0.25cc instead of PREVNAR as indicated at 2 months of age. Pt has been fine with no symptoms.
We were very careful throughout the whole pandemic. We didn't take as much precaution  recently around this time, and I believe we know where we got it. My spouse got it first then I came down with it. The symptoms started on 02/08 and they were congestion, shortness of breath, sore throat, runny nose, headache, and fatigue. No fever. On 02/09/2023, I had a positive test at home. I had a visit with my doctor's PA on telehealth and she prescribed Molnupiravir and Promethazine DM. When I had the positive home test, that was on a Thursday, and by Monday 02/13/2023 the symptoms were gone. The Thursday after 02/16/2023, the symptoms returned again in the evening. Tested again 02/17/2023 and was positive. The following Monday, the symptoms continued with a raspy voice and some congestion. I still had symptoms on 02/20/2023 but I also tested negative at this point. I had fatigue for about another 3 weeks.
This spontaneous report as received from a pharmacist refers to a 92 or 93 year old female patient. The patient's medical history and past drug history were unknown. On 01-SEP-2014, the patient was vaccinated with ZOSTAVAX lot # J004269 expiration date 12-JUL-2014 in the left arm. No concomitant medication reported. On 01-SEP-2014, patient was given the injection and after that the pharmacist realized it was expired. It was unknown if there was any relevant laboratory data. As of 01-SEP-2014, it was unknown if the patient would receive ZOSTAVAX again and the outcome of receiving an expired ZOSTAVAX was unknown. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. Medical assistant reported that the patient had received two doses of GARDASIL and, on an unknown date, had a diagnosis of Narcolepsy. She reported that she was not sure whether the patient suffered from narcolepsy before the GARDASIL series started. The nurse reported that the mother wanted to hold the third dose, until safety information could be obtained about GARDASIL use in narcoleptic patient, so the patient had not yet completed the series. The outcome of narcolepsy was reported as not recovered/not resolved. The relationship between GARDASIL and the narcolepsy was not reported. Patient sought medical attention. Had an office visit. Additional information has been requested.
Narrative:  67yo male pt died in the ER at hospital after coding on 12/14/2021. Death was caused by: cardiopulm arrest, nsc lung cancer, arterial occlucion. HX: tob abuse,severe copd, htn,chf, cabg,cva- local hospital, metastatic lung adenocarcinoma recent hemoptysis, (cancer workup has not been completed, chemo/RT not started), picc line right upper extremity recently removed. Pt had received covid vaccines on 4/5/21 & 3/8/21. This death is not related to covid vaccines.
No adverse event; First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 02L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-646995 (Patient Link).
Pt under 19 years old - original DOB stated as 1990 - found to 1994. No side effects or negative sequelae.
Seriousness criteria other medically significant (OMIC). Initial report received on 7/26/2006 from a health care professional. A 45 year old female pt received a booster dose of Decavac, lot number U1724AA, IM in the right deltoid. Five days later, the pt developed redness approx one inch below the injection site. The redness extended down to the elbow. The pt also complained of tenderness and swelling at the site of injection . The pt was seen by a physician and was treated with oral prednisone. As per the reporter, the pts recovery status is unknown. The reporter of this case is the same as for non serious case 200601913, which involved a report of injection site inflammation following the administration of Decavac, lot number U1596DA.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses od PROQUAD (Merck) (lot # K025760, expiration date: 08-JUN-2016, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left arm was swollen and red around injection site and warm to touch. Six days later, it is less red but still visible.
9AUG93 pt reported a knot on arm; 12AUG93 pt went to the MD & was told by MD that knot was not caused by the shot;
9MAR97 AM aching-elbows, knees, ankles, feet;PM 9MAR97 fever, chills;10MAR97 fever, t101.2-unable to work, unable to sleep;
Patient received vaccine at 08:30.  Patient waited 30  minutes, exited the building did not leave site. patient returned to clinic at 09:10 with complaints of  "feeling like her throat is closing". Dr. assessed  patient, Dr. gave Epi 0.3 auto inject right thigh at 09:16 am. EMS was called at 09:23 am. RN gave 50 mg Benadryl IM left deltoid at 09:30 am,  EMS arrived at 0930. Patient was alert and  orientated talking to EMS. Patient and EMS left Facility at 09:37am. VS 98% RA, 155/66, Pulse 79, RR  18-20.  Patient Stated she had a reaction after first dose at home, she
The decedent was found deceased at home on 05/23/2021. The decedent's cause of death is acute fentanyl toxicity. The pathologist found blood clots in her lungs during autopsy, and she was concerned the blood clots may be related to the vaccine she received on 05/08/2021.
This is a spontaneous report from a contactable Pharmacist via a Pfizer sales representative. The Pharmacist reported similar events for 3 patients. This is case 2 of 3. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration at single dose in the left arm on an unspecified date for immunisation. The patient medical history and medications were not reported. On an unspecified date the patient complained pain at injection site when vaccine was administered with outcome of unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017420662 Same reporter/drug/event, different patient; US-PFIZER INC-2017420666 Same reporter/drug/event, different patient.
Per phone note 2/9/11 - pt's mom states (L) leg immunization site red, hard & size of quarter (on 2/8/11) - now, still red & size of silver dollar. Tx per Doc: Ibuprofen, & ice pack.
No adverse effect reported; temperature excursion / temperature 34.8 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 19-OCT-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # U007652, expiration date 14-APR-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2112USA000788: US-009507513-2112USA000785: US-009507513-2112USA000790: US-009507513-2112USA000789: US-009507513-2112USA000792:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 4th February 2019, the patient received the 1st dose of SHINGRIX. On 4th February 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, muscle pain and general malaise. On 6th February 2019, the outcome of the influenza-like symptoms, fever, chills, muscle pain and general malaise were resolved with sequelae. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, muscle pain and general malaise to be related to SHINGRIX. Additional details were reported as follows: On 4th February 2019, the patient had SHINGRIX vaccine on late afternoon. The patient said that very same night of vaccination she started having symptoms. The symptoms lasted for about 2 days. The reporter did not consent to follow-up.