chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No immediate reaction.  Vaccine given on 10-16-07.  Arm sore on 10-18-07.  To doctor on 10-19-07, hospitalized with possible cellulitis.  Condition deteriorated over this past week, requiring intensive care and ventillator support.  Continues in intensive care on ventillator and have not been able to talk with patient to learn what symptoms were experienced or how they came on.  11/12/07 Link w/294648. 11/06/2007 MR received for DOS 10/21/2007- 11/23/2007.   Pt developed pain at flu injection site.   Subsequently developed fever, chills, and rigors. Seen by PCP and txd with pain med however developed redness and swelling at site and weakness so presented to ER. VS 84/54, 132, 22 and T=101.7'F. PE (+) for LUE very hot with swollen joints. (+) tenderness.  Pt rapidly developed multi system organ failure 2' to sepsis and probable necrotizing fasciitis. Multiple consults:  Surgical: for necrotizing fascitis with multiple organ system failure. Taken to OR x2 for Massive Incision, Drainage and Debridement of L Upper Arm and shoulder portion of the back, R Femoral artery Art Line placement and I & D of flank with extremely large incision. Renal: for Renal Failure/insufficiency.   Cardiac: for tachycardia with PACs. Pt was hemodynamically unstable during first surgery surgery and remained intubated thereafter. Twitching noted by one consultant-small seizures. 11/28/2007 D/C Summary received.  D/C DX: Septic shock.  Respiratory Failure.  Acute Renal Failure resolved.  Necrotizing Fasciitis s/p intubation and extubation. Fever.  Leukocytosis.  Tachycardia.  Hypotension.  Elevated LFTs.  Acalculous Cholecystitis s/p cholecystectomy.  Open Wound.  Metabolic Acidosis.  Rhabdomyolysis.  Systemic Inflammatory Response Syndrome.  Mitral Regurgitation.  Mild Concentric L Ventricular Hypertrophy My mother is still recovering from Necrotizing Fasciitius. She has had 5 toes amputated on her right foot and may need more surgery. She has had a total of 5 surgeries.
Approximately 28 hours post injection I developed profuse sweating that lasted all night (approximately 8 hours).  I do not normally sweat in my sleep.  I did not check my temperature.  I had a brief moment of chills lasting <5 minutes at 10pm.  I did not feel like I was febrile.  I did not take any medication for any side effects.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (lot # L023112, expiry date: 24-DEC-2016, dose, route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Itchiness, bumps, and redness of skin on body, feet, thighs, groin, chest, arms, head. Pressure makes red marks appear that itch. Began day 11 after booster. No reaction to initial 2 doses (also moderna) other than mild fever, malaise, etc for a day or two. No known allergies or previous skin conditions. No changes in diet, medication, etc.
extremely shaking so severe; collapse on the floor; impacted his head and cracked; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (extremely shaking so severe), FALL (collapse on the floor) and HEAD INJURY (impacted his head and cracked) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN, DUPILUMAB (DUPIXENT) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (extremely shaking so severe), FALL (collapse on the floor) and HEAD INJURY (impacted his head and cracked). At the time of the report, TREMOR (extremely shaking so severe), FALL (collapse on the floor) and HEAD INJURY (impacted his head and cracked) outcome was unknown.
Within 3 minutes of receiving vaccine felt flush and throat swelling, responded to Epi Pen and Benadryl p.o. EMS took him to ED where he remained several hours receiving 1 liter NS 125 mg solumedrol IV, discharge with 4 days of prednisone 40 mg daily and a prescription for an Epi Pen.  As of 1.12 he is totally okay with no after effects.
Localized swelling 3 cm in diameter starting 13 days after injection with pain. No redness or signs of infection.
Patient describes a rash that appeared on arms and legs.  She felt feverish, and tired. Rested all day and the rash is going away. She is feeling better at 5pm.
Pt described bumps under buttocks, starting around 7:00pm the evening of the vaccine. These spread into hives and welts on the backs of the thighs, from under the buttocks to the top of the backs of the knees. Pt reports the hives as itching and stinging, and not improving with steroid cream and antihistamine prescribed by her teledoc.
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # was reported as L00559, complete lot number was not provided) and the lot # was an invalid lot # for RECOMBIVAX HB, expiration date 15-APR-2017, dose, dose # and route unknown. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Extreme pain at injection site. Unable to move from lying down for 2+ hours. Required leftover narcotic to get enough relief to move to bed. Onset progressed from achey shoulder to on the floor very abruptly.
3 days after 3rd dose HPV vaccine - developed labial and vaginal ulcers - slight fever and HA. Progressed to be very painful.
swelling in the roof of her mouth, and it did go to her ears; swelling in the roof of her mouth, and it did go to her ears; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number: EN6198, Expiry date: unknown), via an unspecified route in the right arm on 25Feb2021 (age at vaccination: 73-year-old), as a single dose for covid-19 immunization. Medical history included she does have a problem with her throat with IV Dye, so she usually gets loaded up with Benadryl or whatever they use before she gets IV dye. The patient concomitant medications were not reported. Patient confirms that she had no other vaccines on the same day as the COVID Inoculation. On 25Feb2021, when patient got the vaccine, she waited the 15-minute timeframe, and during that time, she felt like a swelling in the roof of her mouth, but not in her throat, like she could breath and swallow. Patient reported that the swelling in the roof of her mouth did go to her ears, but it seemed gone by the time the patient went home. She asked her PCP if she could take Benadryl with the next dose, and he said it shouldn't hurt the vaccine, but the patient wants to make sure. Patient is wondering if she should take Benadryl the night before the second dose, or the morning before, is Benadryl okay to take with the product. The clinical outcome of the events was recovered/resolved completely that same day (25Feb2021), she even ate veggie soup with no problems with her throat.   No follow-up attempts are possible. No further information is expected.
Skin has sandpaper or chicken skin rash mostly over back, some on upper thorax. Pt felt burning sensation over back.
Caller (NURSE PRESCRIBER) called to know about need to give a 3rd dose of GARDASIL 9 to a female patient (23 years old); No other AE/PQC reported.; second dose of HPV 4 or GARDISIL 9 on 7/3/2017. The second dose was not in the recommended interval, it was late.; second dose of HPV 4 or GARDISIL 9; This spontaneous report was received from a nurse prescriber referring to a currently 23-years-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 15-AUG-2014 (also reported as when she was 14-years-old, per her immunization record), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (reported as human papillomavirus vaccine [HPV 4]) (exact dose, route of administration, anatomical location, lot number and expiration dose were not reported) for prophylaxis.  On 03-JUL-2017 (per her immunization record ), the patient was vaccinated with a second dose of either of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (reported as HPV 4) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) (exact dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis; the second dose was not in the recommended interval, it was late (inappropriate schedule of product administration, interchange of vaccine products). Caller was not able to clarify about the HPV 4 or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) and what patient received, as on the immunization record it stated "HPV 4". Caller stated there was no record of the patient getting the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) and the patient was not sure if she received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) or not. Caller wanted to know if they can give/the need to give her the third dose of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDISIL 9) (inappropriate schedule of product administration). No other adverse event (AE)/ product quality complaint (PQC) was reported (no adverse event).
COVID 19 Treatment; COVID 19 Treatment; A 70-year-old female patient received BNT162b2 (BNT162B2), on 09Aug2021 as dose 2, single (Lot number: pf13er) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received other medication in 2weeks. Product: COVID 19 Treatment. Brand: paxlovid. Treatment start date: 15Jul2022. Treatment stop date: 18Jul2022. Lot number: 1917995A. Patient did not have known allergies.; Sender's Comments: As per available information the causality of the event covid-19 and the suspect product BNT162B2 can't be ruled out.
This spontaneous report was received from a physician referring to a 15 year old female patient with not known allergies. Medical history, concurrent conditions and concomitant medication were not reported. On 20-OCT-2016 (approximately between 03:03PM and 03:10PM), the patient was vaccinated with the second dose of GARDASIL 9 injection (intramuscular deltoid left arm, lot # M009378, expiration date 23-APR-2018). The same day, after vaccination, the patient stood up in less than 15 minutes fell, and briefly lost her consciousness. Hit her head (head injury) either on the floor or the wall. The patient was observed to have a seizure for 30 seconds (also reported 1 minute). When the patient became alert she had headache. The physician stated that on an unknown date in October 2016, the patient was hospitalized due to the adverse events and was still on an unspecified treatment for the experience. The outcome of fall, loss of consciousness, head injury, seizure and headache was unknown at the time of reporting. The causal relationship between GARDASIL 9 and the events was unknown. The physician considered fall, loss of consciousness, head injury, seizure and headache were medically significant. Additional information has been requested.
I have had several lymph nodes swell up on my right side of my body. They have been showing up on my face, hands, legs. I went into my doctor for an appointment for a regular checkup. He noticed my blood count was up. He sent me to an oncologist for more specific blood work up. The results for the bloodwork showed positive for polycythemia vera. I am currently having my blood drawn, I am not doing chemotherapy or radiation.
Right eye twitching, pain behind ears and facial paralysis to right side of face, cannot smile
One day post vax, the patient experienced a rash at the site of the injection. He also experienced a rash on the abdomen. Medical attention was sought. No further information could be obtained from the health professional because a patient name was not supplied.
for 48 hours post vaccination I had headache, fever, body aches, stiff neck, extreme fatigue, nausea
Patient reported full body hives started 5 days after her 1st COVID Pfizer vaccine that went away, but when she received her 2nd dose the hives showed back up the same day and did not go away for 9 months when the patient received medical intervention.
pt recvd vax 29JUL94 that evening pt cried inconsolably for 3 hrs; APAP orally was used q 4 hrs;
simply had a sore arm at the injection site; This is a spontaneous report from a contactable physician reported for himself. A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE brand: Pfizer, lot number: EL0140), via intramuscular at left arm on 22Dec2020, 10:00 AM at a single dose for COVID-19 immunisation. Facility of the most recent COVID-19 vaccine was administered in Nursing Home/Senior Living Facility. There were no allergies to medications, food, or other products reported, other medical history included: migraines, rosacea, overweight (not obese). Concomitant medication included (patient received within 2 weeks of vaccination) doxycycline, magnesium, vitamin d, sulfamethoxazole, trimethoprim (BACTRIM). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. For the first 24 hours, patient simply had a sore arm at the injection site with the first vaccination. It was reported serious criteria as no, no results in death, no life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was unknown. Patient received the second dose of BNT162B2 on 12Jan2021, 11:00 AM (refer to AER 2021028085).
temp of 101.4 on 6/13/2020, larger than golf ball size lumps on BIL thighs in injection areas that were hard, painful, red, and itchy. Lumps resolved 6/16/20, but dark, discoloration remains. No fever since 6/14/2020.  See by physician (Dr.) on 6/16/2020 and doing much better.
intestinal infection; This case was reported by a pharmacist via call center representative and described the occurrence of ill-defined intestinal infections in a female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced ill-defined intestinal infections (serious criteria GSK medically significant). On an unknown date, the outcome of the ill-defined intestinal infections was unknown.   It was unknown if the reporter considered the ill-defined intestinal infections to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix and had intestinal infection. The patient took medication for the infection hence reporter wanted to know whether patient could receive 2nd dose of vaccine or not. The batch number of Shingrix was reported as 29759, However, as per sales data sheet the batch number was updated to 29T59. The reporter consented to follow up.
I have numbness from my forehead down to, down to my neck on my right side; it also feels like have food stuck between my cheek and gum; I didn't sleep; It just feels weird; the other side of my face where I got the vaccinated on that started going numb as well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Formulation: solution for injection; manufacturer: Unspecified; Lot number; NDC number; UPC number and Expiry Date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the vaccine on Saturday (unknown date) and had numbness from forehead down to, down to the neck on the right side and it also feels like have food stuck between the cheek and gum, and checked last night, patient did not sleep on an unknown date and checked last night and did not have any food stuck in there because patient brush teeth before going to bed and gargle and everything else what the patient do every night and it just feels weird and the other side of the face where patient got the vaccinated on that started going numb as well, on an unknown date. The reaction to the vaccine, that the patient should be concerned about or not. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report was received from an office manager via field representative refers to a currently 66 year old female patient. On an unknown date (reported as while back on), the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not reported). On an unspecified date in 2014 (also reported as within the last few weeks) the patient developed a severe case of the shingles, particularly on her face and neck. The reporter stated that the patient visited an unspecified emergency room where she received the diagnosis. It was not known if patient was admitted to the hospital. The outcome of developed a severe case of the shingles, particularly on her face and neck was unknown. Additional information has been requested.
Patient received 2nd dose of vaccine 5/5/21. Afternoon of 5/5/21 experienced extreme tiredness. Starting 5/6/21, patient was experiencing a throbbing pain in bones all over her body.  Pain came and went, off and on all day. on 5/6/21 Patient also experienced low grade fever, chills, and some mild nausea. Patient reported these side effects via V-safe program. Starting 5/7, patient's other symptoms resolved, however patient noticed a moveable node on the left base of her neck right above her clavicle.  Patient plans to observe node to make sure it resolves, will check in with provider if node not resolved after a couple weeks.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old male patient who received SHINGRIX. Concomitant products included PLAVIX, Atorvastatin, hydrochlorothiazide and lisinopril. On 7th May 2018, the patient received SHINGRIX. On 7th may 2018, immediately after receiving SHINGRIX, the patient experienced fatigue, unsteadiness and spinning sensation. On an unknown date, the outcome of the fatigue and spinning sensation were recovering/resolving and the outcome of the unsteadiness was unchanged. The reporter considered the fatigue, unsteadiness and spinning sensation to be probably related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. The patient received SHINGRIX in the left arm. The patient had a blood draw for laboratory on the same office visit. About 40 minutes after receiving SHINGRIX, the patient was home and had to take a nap. Less than a day after receiving SHINGRIX, upon awakening, the patient stated that, the room began to spin and he felt unstable.
This spontaneous report as received from nurse refers to a 14 year old female patient with attention deficit disorder and anxiety and with no drug reaction or allergies. On 14-JUL-2011 the patient was vaccinated with first dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided), on 25-JUL-2012 patient received second dose of GARDASIL (dose, route of administration, lot number and expiration date were not provided) and on 21-NOV-2013 patient received third dose of recalled GARDASIL (lot number: J007354, expiration date 20-FEB-2016) (dose and route of administration were not provided). Secondary suspect therapy included FLUMIST which was given on 21-NOV-2013. Concomitant therapies included ADDERALL XR and CELEXA. It was reported that patient complained of headache on 04-JAN-2014 and she went to bed early that night. It was reported that "she never woke up". Patient died on 04-JAN-2014. Nurse has not been informed of the autopsy result so she could not determinate cause of death. Lab diagnostic studies were not performed. It was also reported that approximately 27 doses of the recalled lot of GARDASIL were also administered at reporter's facility but she has not heard of any other adverse effects. The outcome of headache was unknown. The relatedness between death, headache and GARDASIL was unknown. Additional information has been requested.
ECZEMATOUS REACTION BILATERAL TO FEET ANTECUBITAL FOSSA; AND NECK. ITCHY ERYTHEMATOUS PAPULES NO PREVIOUS NO HISTORY OF ECZEMA. SEVERE EDEMA ON FEET; REQUIRED QUARTERS FOR THREE DAYS. ORAL ANTIHISTAMINES AND TOPICAL STEROIDS.
On the day of the vaccine, I passed out in a store and puked in the parking lot. I also experienced extreme chills and headache. My entire body ached for the rest of the day.  On the day after the vaccine I felt much better, but I did have diarrhea.