chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED visit and hospital admission for Open reduction and internal fixation left distal radius fracture. the patient was discharged to home under satisfactory medical and post-operative condition. This visit was within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a doctor of pharmacy, concerning a two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 22-MAY-2017 and 23-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lot number reported as M00343 with expiration date of 19-JAN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. No adverse reactions were reported. It was also reported that on unspecified dates, the administered doses experienced temperature excursions during 15 minutes, 20.5 hours and 2.25 hours, at a temperature between -14 degrees Celsius and -10 degrees Celsius, -9 degrees Celsius and 8 degrees Celsius, and 9 degrees Celsius and 25 degrees Celsius, respectively. No previous temperature excursion was reported. A data logger issue was involved. Lot number M00343 is an invalid lot number for varicella virus vaccine live (oka/merck). Additional information has been requested.
I was advised to get the new SHINGRIX two part vaccination, being told it was "safe" for sufferers of rheumatoid arthritis. I had the first dose in May, and simply had moderate pain at the injection site for three days. I had the second dose last night and within an hour I could lift arm as the injection site hurt so much. This morning I woke in full RA flare with fatigue, confusion, headache, fever, chills, and the injection site is still painful at 5 out of 10. There is slight redness and swelling at the injection site. 400 of ibuprofen every five hours and 3 mg. prednisone seem to knock the edge off the severity of the symptoms. I called my rheumatologist, and his nurse suggested I try and even higher dose of prednisone. If it's not necessary, I won't do it.
mild shaking; sore left arm  at injection site; Severe headache; flu-like symptoms; mild aches and pains; cough; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA QUAD) for prophylaxis.   Concurrent medical conditions included allergy (was unspecified).   On 28th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of AFLURIA QUAD. On 28th September 2020, less than a day after receiving Shingrix and an unknown time after receiving AFLURIA QUAD, the patient experienced injection site pain, headache, flu-like symptoms, pain and cough. On an unknown date, the patient experienced tremor. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, headache, flu-like symptoms, pain, cough and tremor were unknown.   It was unknown if the reporter considered the injection site pain, headache, flu-like symptoms, pain, cough and tremor to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and flu vaccine Afluria Quad on the same day. The patient reported that she developed a severe headache, flu like symptoms, mild shaking, a sore left arm at injection site, cough, mild aches and pains. The patient stated that developed the symptoms within 10 hours of receiving the 1st dose of Shingrix. The patient  took Advil for the symptoms. No further information was available. The reporter consented to follow up.
Lymph glands under left arm became swollen and quite painful within several days/ pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month; Lymph glands under left arm became swollen and quite painful within several days/ pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jun2021 13:31 (Batch/Lot number: unknown) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 14Jun2021 08:00, outcome "recovered" (13Jul2021) and all described as "Lymph glands under left arm became swollen and quite painful within several days/ pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. It was reported that the patient had no relevant test. It was reported that lymph glands under left arm became swollen and quite painful within several days of receiving the shot-the pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month after the shot. Several days following my first Covid-19 shot, the patient began to notice that the lymph glands in her armpit on left side, (received shot in left arm) were beginning to swell and were moderately painful. Over course of next several days, pain and swelling spread to lymph glands in her upper left chest near her collar bone. The pain and swelling lasted just about a month. the patient stated that she wasted until it was gone completely before receiving second shot in other arm. It was reported that the Pfizer have permission to contact the reporter about this event and also have permission to contact patient's healthcare provider about this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bumps roof of mouth numbness right side lips rash right arm 15 min. after injection went to ER still on Benedral 9/13/19
Shortly after receiving influenza vaccine, patient stated he felt lightheaded and dizzy. Instructed patient to lean back in chair and take nice slow deep breaths. Then patient became unresponsive with head leaning against wall behind chair, snoring loudly, did not respond to name or moving his arms, then incontinent of urine. Medical emergency button pressed, 9 - 1 - 1 called, pharmacist came to assist and stated would direct EMS when they arrive. This writer placed pulse ox on patient, assessed heart and lungs and pertinent vitals. Patient back alert after 2 minutes and able to recall all events leading up to unconsciousness and states has not experienced any episodes of this in the past. No history of seizures, narcolepsy, or heart conditions.  Patient states does not want to go to Emergency Department and called his wife (whom he states is a nurse). EMS arrived and also assessed vital signs and obtained blood sugar of 78. Patient reiterated to EMS that he does not want to go to Emergency Department. EMS called to report to hospital patient's refusal and left patient in my care. Patient's wife arrived to take patient home in stable condition.
4/12/2004-LUT swelling noted last night. Hot to touch at site of injection. No raise in temp. 4/13/04 -phone call to mom. Clients leg looks much better today. Swelling down. No longer hot to touch. 4/22/04 follow up with mom. No further problems and lump gone.
This spontaneous report was received from a licensed practical nurse refers to a 2 year old female patient. The patient's medical history and drug allergies were none. Concomitant therapies included THERAFLU which was given on 06-MAR-2016. On 09-MAR-2016, the patient was vaccinated, into her left thigh, with PEDVAXHIB (Lot# L030870, expiry: 10-JUN-2016) (dosing details not provided). In the evening of 09-MAR-2016, the patient broke out into hive like rash which began at the injection site. The patient sought medical attention and visited the office on 10-MAR-2016 and the hive like rash had spread across patient's entire body. The patient was diagnosed as having an allergic reaction to the PEDVAXHIB. The patient was treated with BENADRYL and prednisone. No lab tests were performed. The outcome of the urticaria was reported as not recovered/not resolved. The relatedness between the event urticaria and PEDVAXHIB was reported as related. Additional information has been requested.
Deep vein thrombosis (DVT) of axillary vein of upper right extremity, sub clavain vein and pulmonary embolism of right and left lung.  Treated with injected Lovenox.
On 10/10, patient received the 3 vaccines in the oncology clinic. On 10/11, patient developed swelling to the vaccination site on her right arm. Denies pain but c/o itchiness. Patient was monitored in the ER.
I received my first shot at the end of January but was unable to get my second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first shot at the end of January but was unable to get my second) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my first shot at the end of January but was unable to get my second). In January 2021, PRODUCT DOSE OMISSION ISSUE (I received my first shot at the end of January but was unable to get my second) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up information received contains non-significant information.
Information has been received from a field representative who received reported AE information from a pharmacist regarding a 69 year old female who was administered ZOSTAVAX (lot# 670820/0660AA, expiration date 04-AUG-2012) on 24-APR-2012. "A few weeks later", the patient developed a rash starting on her neck. The rash "looks like chickenpox". The patient had been evaluated by an unspecified dermatologist but the rash had been persistent. No further details were noted. No further information is expected.
Red, itchy, painful rash at injection site 8 days after receiving the Moderna vaccine (began 3/6/2021)..  Continues for a second day ( today, 3/7/2021).
Rash behind both knes, rash on  both thighs, rash on the chest area, rash on both elbow, all the rash is red
"Covid Arm" - Redness, Swelling, Itching, painful to touch.
Vaccination site warmth; vaccination site rash; Itching at injection site; hardness at injection site; redness at injection site; tenderness at injection site; bad pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bad pain), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (bad pain), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (tenderness at injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (vaccination site rash). The patient was treated with AMIKACIN SULFATE (AMICA) at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. At the time of the report, PAIN (bad pain), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a RN concerning her 1 yr old daughter who on an unspecified date, was vaccinated SC with a single 0.5ml dose of MMR (+) varicella virus vaccine live. Eight days after vaccination, the pt developed a high temp ranging from 99 to 103 degrees. The pt also had seizures. The pt's mother felt that the high temp was life threatening. Unspecified medical attention was sought. There was no product quality complaint involved. The child fully recovered. Upon internal review, seizures were considered to be an other important medical event (OMIC). The pt is one of triplets, her sisters (WAES0608USA05187 and 0608USA05188) also had adverse experiences after vaccination with MMR (+) varicella virus vaccine live. Additional information has been requested.
11pm the same day I started getting sever aches and chills.  This progressed and a fever also developed.  I rotated tylenol and ibuprofen all  day and ran a 102 fever with that. I was so cold my body shivered uncontrollably at times.  The next day a developed a small dry cough and felt winded after walking.  My heart rate as elevated all day.  My normal resting rate is 60 and yesterday it was 75.   After about 36 hours of this my fever broke and I have felt better each hour since.  I have not felt this sick due to chills and aches in many years.  I found it strange that my the cough stopped within a day.  Other strange symptoms included pain the same Location of the shot but in the opposite arm  and I got the shot on day three of my monthly cycle, it basically stopped that day which is unusual It normally lasts 5 days.
While working on duty for the Fire Dept, I was bitten by a ferrel cat. After a thorough 3 day search search
NECK PAIN; This spontaneous report received from a consumer received on 14-MAY-2021 and concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Batch number was not reported and has been requested. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine  was not applicable. The outcome of neck pain 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.
nausea, tiredness began within hours along with very sore arm.  Continued next day and by 6/18 included chills, headache and more nausea.  By Wed and till Sat. 6/29 experienced severe GI cramping and incredibly frequent and painful urination.  Pain peaked so severely by 6/23 I went to ER.  Symptoms mildly improved thereafter and totally disappeared over a few hours on 6/29.  On 6/25 suddenly began having chest pain/tightness, lightheadedness and difficulty breathing after even the slightest exertion (a flight of stairs.  These symptoms peaked 6/29 and faded totally between 7/5 and 7/8 when I was able to resume normal activities.
Just a constant ringing in my ears.   Comes on strong sometimes, fades away and returns.   Usually worse when quiet - but I might just not be hearing it when it's loud.
the patient was in a room with two other vaccinated individuals, in a meeting, without masks; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient was in a room with two other vaccinated individuals, in a meeting, without masks. It was reported that on Thursday, 05Aug2021, the patient learned that one of the persons who had the Pfizer COVID vaccine had tested positive for Covid 19. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt was being changed by g'ma on changing table. Had tonic seizure x 5 min. EMS arrived. Pt post ictal afebrile. Sent to ER for eval.
Pt. states after receiving the Janssen vaccine, 06/19/2021 started experiencing vertigo, chest pain, and Migraine. ER visit 06/23/2021 continuing to experience the symptoms continuing for 10 days. Blood Test ran showing low white blood cell count. Resuming normal activity but continuing to experience short time of vertigo but no longer symptoms.
6/27/03: Evaluated left deltoid area. Swollen and red over entire deltoid. Warm to touch and firmness. Appeared to be developing cellulitis over entire area. Referred to ER, no doctors in clinic available. Pt stated unresponsive to Benadryl and ice.
on Wednesday afternoon, the day after the booster/vaccine, I felt fatigued and light headed after exercising. I came home and had chills, fever and loose stools, which lasted for approximately 36-48 hours. I also had a runny nose and congestion--seemingly cold symptoms--that lasted through the weekend. On Sunday evening (12/19/21) I noticed that I had no sense of taste or smell, an odd symptom that occurred for the first time in relative absence of any other symptoms (aside from mild congestion).
Shortly before 1900 on 9/28/2022, pt. lost consciousness, fell out of a chair, and hit her head on the ground following receipt of the influenza vaccine. She was attended to by preceptor and faculty. She lost consciousness for less than 60 seconds. After regaining consciousness, she was awake and alert, able to state her name, and aware of where she was and what happened. She responded appropriately to questions (has this ever happened before, did you eat, how are you feeling). Blood pressure and heart rate were recorded and were within normal limits. The patient remained in a supine position for approximately 10 minutes before attempting to rise to a seated position. She tolerated this movement well and, after a few minutes sitting up on the ground, attempted to stand with support from clinic preceptors. She tolerated standing well, was able to see without difficulty, and felt well enough to return to her room. She was instructed to have her roommate monitor her for the remainder of the evening and to have her roommate call EMS if she lost consciousness again. She left the clinic area at approximately 1915 in good condition.
product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: FF8841), in left arm, on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LISINOPRIL; MONTELUKAST. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "not recovered" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Negative; (22Apr2022) positive; (27Apr2022) positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: After completing her paxlovid meds on17Apr2022, her symptoms were gone and she tested negative on a home covid test on 18Apr2022. On 22Apr2022 she developed covid symptoms again and tested positive on a home test. She currently was still testing positive on 27Apr2022 and have cough and congestion. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
screaming x 1 hrs treated w/APAP; 3SEP93 recovered 1 hr p/APAP;
Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"; both palms started pilling; Blisters in those places that he was pilling - looks like leprosy; his thumbs are pilling too; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"), BLISTER (Blisters in those places that he was pilling - looks like leprosy) and SKIN EXFOLIATION (his thumbs are pilling too) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Overweight and Smoker.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VERTIGO (Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"), BLISTER (Blisters in those places that he was pilling - looks like leprosy) and SKIN EXFOLIATION (his thumbs are pilling too). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, VERTIGO (Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"), BLISTER (Blisters in those places that he was pilling - looks like leprosy) and SKIN EXFOLIATION (his thumbs are pilling too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. Treatment medications taken were readjustments for the "crystals" in his ears, Benadryl and 2 Aleve or Advil.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: no new information
pt recv vax 3SEP97 & on 12SEP97 pt presented w/lymphadenopathy;
Headache, Arthralgia & Fever Narrative: HA , Nausea Fever Joint pain