chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 27MAR98 & 20min p/vax pt exp sore arm injite;over the period of the next 45min to an hr, pt also devel worsened arm pain extending into neck w/some difficulty swallowing;28MAR98 pt c/o pains in chest & back along, w/n/v/d;
3" weal, warm to the touch, itchy, below injection site noticed 24 hours after injection and persisting at day 3
Fever Stomach ache Loss of Appetit Cold stuffy nose  Difficulty breathing         Lasted about  24 hours with acceptation of the stuffy nose (Cold)
Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On  07-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Client received the 2nd COVID vaccine (Pfizer Lot # EW0185 and 06/19/2021) at 1906. At 1917 client was sitting in the observation area when he suddenly ran to one of the trash cans and started throwing up. PHN  and EMT responded and assisted client into a chair and gave him an emesis bag. The client threw up one more time into the bag. Client stated that he ?suddenly felt nauseas, almost feels like a nervous reaction.? Client stated, ?I felt chills down my spine that traveled into my arms and my fingers tingled and my ears got hot. It felt like a hotflash.? Client was alert and oriented times four, and his skin was warm, and color was appropriate to race. Vital signs were taken at 1919 (blood pressure 110/78, heart rate 76, oxygen 96%). Client stated at 1921 ?I?m feeling better now,? and that the nausea had subsided. Vital signs were taken at 1924 (blood pressure 122/72, heart rate 73, oxygen 94%). Client was offered Benadryl by PHN and client refused. Client stated that he was feeling worried about receiving his second dose of the vaccine, ?we know someone who got their second dose a couple weeks ago and was paralyzed from it.? Client also stated that he was working outside in the sun all day. Vital signs taken at 1934 (blood pressure 122/80, heart rate 75, oxygen 96%). Client offered juice by PHN and he accepted and drank it. Client does not have any medical conditions, is not on any medications, and does not have any allergies. PHN advised client to follow up with his primary care provider, and education was provided to client on life threatening symptoms and to seek emergency services if he developed any. At 1947 client stated, ?I?m feeling fine,? and he left the facility unassisted with a steady gait.
One week after getting my first Pfizer shot, I got a rash on my right arm opposite side of elbow.  It's around 2 inch by 2 inch and is sometimes itchy.
This spontaneous report was received from a physician and refers to 4 non-pregnant patients of unknown age and gender that the physician had within the last several months. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, lot # and expiry date were not reported). On unknown dates, about one hour after receipt of PNEUMOVAX 23, the patients experienced extreme arm and shoulder pain. The arm pain gradually increased over a few days, then decreased - total time to resolution was about 3-4 days. The reporter noted that a few of the patients (unspecified number) had such severe pain, they could not move their arm, and that they went to emergency rooms (hospital unspecified) in which they had blood work drawn, which showed elevated white blood cell counts. The patients received unspecified treatment for the events. The reporter also stated that one of the patients had such severe shoulder pain, that he went to an orthopaedic physician and was determined to have a torn ligament. This patient's pain was treated with hydrocodone. The patients recovered from arm pain on an unspecified date. The outcome of the events of shoulder pain, patients not being able to move their arm, white blood cell count elevated and torn ligament was not reported. Causal relationship between the events and PNEUMOVAX 23 was not provided. The orthopaedic physician considered the event of torn ligament to be not related to PNEUMOVAX 23, however the reporting physician did not provide his own assessment. Product quality complaint was not involved. Additional information has been requested.
left arm like the area got really big and swelled up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "heart problems" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "left arm like the area got really big and swelled up". Therapeutic measures were taken as a result of vaccination site swelling.  Additional information: It was reported that the patient was on a lot of medicine since she has heart problems, was on oxygen and has a lot of other medical issues. It was reported that the patient received antibiotics for the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Uncontrollable shivering/tremors for 20-30 mins following shower despite warming efforts (blankets, warming pad). House was normal indoor temperature (approx 70F).
Pt vaccinated with Moderna COVID vaccine shot number 1.   scratchy throat started 5 minutes afterward.   Tongue was tingling.  throat was dry.   no stridor or wheezing.   initial BP 128/82 pulse of 80   )2 sat of 100%.  normal mucous membranes   no wheezing  initially no rash.     then complained her ears were hot.  Shortly thereafter developed a flush on the upper chest and face and ears.    1/9/2021 11:59 AM Patient light headed.   Ears feeling hot.    1/9/2021 12:02 PM patient has flushing of face and upper chest. Denies itching. 1/9/2021 12:03 PM patient reports itching of neck. blood pressure 118/78 1/9/2021 12:13 PM   Sitting up   Flushing is slightly better  1/9/2021 12:41 PM    Sitting up  Flushing has resolved.  130/70  Pulse 52  96% sat  Patient is feeling back to normal Discharged to home  OK to get second dose.    the patient did take 10 mg Claritin about 90 minutes before the vaccination.     she takes Claritin daily .     we have sent her home    no symptom s
Following immunizations, patient had swelling of the lips for 1-2 days.  Eight days later he developed a rash starting on his buttocks and face and spread throughout his body.  Slightly raised red dots not itchy.  Parents refused to return my calls.
The area around the injection site , and extending 4? across at the widest part, was red, raised, warm and sensitive to the touch. There was also a red line, about 1.5-2? in length, streaking across my arm from the injection site, that lasted a day.  So far, it has been 4 days that I have experienced this redness, soreness, etc. I took a shower about 3 hours after the vaccine and I wonder if I accidentally moved the dose around, I don?t think I was being that rough on my skin though.
PT states headache/muscle ache/dizziness/chills (received J/J at today 1100). Denies dizziness at this time.
DAYS 1-4 NOTHING BUT NORMAL REDNESS AND WARM TO THE TOUCH. DAY 5 CLEARED UP NOTHING THERE. DAY 6-7  WATER BLISTERS, VERY SWOLLEN AND HARD. DAY 8 MUCH BETTER AND NOT AS HARD
2:45pm  less than ten minutes post vaccination c/o severe headache.  BP elevated above normal greater than 180/ denies dizziness.  Hx of DM currently on holter monitor. Hx of MS 2:50pm BP 179/81HR 69 SPO2 99% 2:55pm BP 180/81 HR 66 SPO2 99% 3:08pm BP 171/76 HR 64 SPO2 99% 3:25pm BP 185/79 HR 62 SPO2 100% 3:30pm EE verbalized feeling much better able to ambulate per self went home.
I had an onset of cough, flu-like symptoms and a fever.  I went to urgent care and was treated for an upper respiratory virus.
Information has been received from a consumer concerning her 84 year old mother who received PNEUMOVAX (lot # not reported) while she was in the hospital, and developed redness, pain and swelling of her arm at the injection site.  The patient sought medical attention.  No other information was available.  Additional information is not expected.
Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was unknown if patient was under any concomitant or regular medication.  Patient asked if she could take Tylenol for fever.   Reporter did not allow further contact
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 30-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Covid-19; papular rash to b/l LE; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid-19) and RASH PAPULAR (papular rash to b/l LE) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Anxiety, Depression, GERD and Allergy to nuts (Tree nuts). Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), LEVOCETIRIZINE, MONTELUKAST, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced RASH PAPULAR (papular rash to b/l LE). On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 25-May-2022 to 27-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown and RASH PAPULAR (papular rash to b/l LE) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included antihistamines and  Device Date was reported 27-May-2022.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender, with relevant medical history of Asthma, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine (Primary doses - unknown). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, and developed a papular rash one day after starting treatment. The outcome of the event was reported as not resolved. The patient's medical history of Asthma puts the patient at a higher risk of developing COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with relevant medical history of Asthma, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine (Primary doses - unknown). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, and developed a papular rash one day after starting treatment. The outcome of the event was reported as not resolved. The patient's medical history of Asthma puts the patient at a higher risk of developing COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient is 87 years old with past medical history of COPD, diabetes, GERD, hyperlipidemia, hypertension, obstructive sleep apnea presented to the hospital with a chief complaint of shortness of breath associated with fatigue and weakness.  Patient had a recent admission to the hospital January 17 for COPD exacerbation.  He was discharged home on oxygen.  He has been encountering difficulty ambulating at home and fulfilling daily needs.  Otherwise patient has no fever, chills, chest pain, abdominal pain, nausea, vomiting, diarrhea, constipation, difficulty urination, dysuria.   In the ED, patient had CT angio of the chest which was negative for pulmonary embolism.  Labs significant for mildly low sodium level.      Clinical Summary   Patient was admitted to the medical surgical unit due to chronic respiratory failure related to COPD exacerbation secondary to COVID-19 infection.  He did not meet criteria for remdesivir.  He was treated with steroids, azithromycin, and bronchodilators.  On hospitalization day 3 patient was feeling improved and agreeable to discharge.  He was assessed on his new baseline oxygen of 2 L and did well.  He did not require further titration of his home oxygen.  Notably, he did have an element of hyperglycemia during hospitalization related to steroid use.  He is discharged on short course of sliding scale insulin while on steroids.  He has a glucometer at home and understands how to check his glucose and insulin administration which was reinforced by myself and nursing.  He has been started on a maintenance inhaler.  He has an appointment with his primary care doctor on Monday.  Patient denied further questions or concerns and was agreeable for discharge.  Home health referrals been placed.   Discharge diagnosis Acute exacerbation of COPD COVID-19 infection Chronic hypoxic respiratory failure Debility/generalized weakness Type 2 diabetes Hypertension Hodgkin's lymphoma Obstructive sleep apnea COVID-19 infection Protein calorie malnutrition next
This spontaneous report as received from a medical assistant refers to a 10 month and 10 days old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 19-FEB-2019, the patient was vaccinated with the forth dose of ROTATEQ orally (lot # R016271 with an expiration date on 25-APR-2020) for prophylaxis (strength, dose, lot number and expiration date were not reported). No adverse effects reported.
conjunctivitis of left eye only beginning the day following vaccine injection; hive-like rash on left arm below injection site emerged 26 APR 2021 and is continuing to spread on left arm only at this point (2 MAY 2021).
no history of miscarriage until the most recent pregnancy with the COVID vaccine. I previously had 4 healthy pregnancies and 4 living children (now 5 pregnancies and 4 living children).  I conceived on 12/18/2020 the day after I received my 1st covid vaccine. I began spotting blood on 3/7/2021 and miscarried an approximately 7 week old embryo. I had a D & C procedure to remove the baby that stopped growing weeks before ( I was 14 weeks and 1 day into my pregnancy before the miscarriage).Due date was sept 4th 2021.
Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022. Patient documentation shows the lot number for bivalent.  The information was presented to hospital staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a 0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at the time of call. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinated. Patient made aware will reach out to patient regarding receiving full vaccination. Patient
4 days after receiving my second dose of the Pfizer CoVid vaccine I woke up at 3am, with an itchy rash that spread over my entire body (scalp to feet) and  progressed an additional day (day 5 post shot)
Starting 11/30/2022, I had a scratchy throat and persistent cough, fatigue and back pain. I tested myself on 12/03/2022 for COVID-19 and was positive. My asthma was really bad and I called my PCP on 12/5/2022 and they prescribed me prednisone 50mg for 5 days and TESSALON PEARLS. After taking 3 of the steroids, I felt totally fine. I am doing good today and totally recouped. I had a previous breakthrough case in 01/2022 which was much worse.
arm stay red and swollen for a quite a few a days; arm stay red and swollen for a quite a few a days; and the next morning she was very tired, and she was tired until  the 4Jul2022, and very gradually started to get energy; at the top was red swollen; at the top was red swollen; lymph nodes were swollen,felt like a rock under the arm, like she had breast cancer,at the top was red swollen and it was huge,; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (at the top was red swollen), SWELLING (at the top was red swollen), LYMPHADENOPATHY (lymph nodes were swollen,felt like a rock under the arm, like she had breast cancer,at the top was red swollen and it was huge,), FATIGUE (and the next morning she was very tired, and she was tired until  the 4Jul2022, and very gradually started to get energy) and VACCINATION SITE ERYTHEMA (arm stay red and swollen for a quite a few a days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 025L20A and 013A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Allergies: No Patient ever had COVID Positive test or diagnosis: Unknown Medical history: No.  Concomitant products included VITAMINS NOS, ASPIRIN [ACETYLSALICYLIC ACID] and FISH OIL for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022, the patient experienced ERYTHEMA (at the top was red swollen), SWELLING (at the top was red swollen) and LYMPHADENOPATHY (lymph nodes were swollen,felt like a rock under the arm, like she had breast cancer,at the top was red swollen and it was huge,). On 28-Jun-2022, the patient experienced FATIGUE (and the next morning she was very tired, and she was tired until  the 4Jul2022, and very gradually started to get energy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm stay red and swollen for a quite a few a days) and VACCINATION SITE SWELLING (arm stay red and swollen for a quite a few a days). On 04-Jul-2022, FATIGUE (and the next morning she was very tired, and she was tired until  the 4Jul2022, and very gradually started to get energy) had resolved. At the time of the report, ERYTHEMA (at the top was red swollen), SWELLING (at the top was red swollen), LYMPHADENOPATHY (lymph nodes were swollen,felt like a rock under the arm, like she had breast cancer,at the top was red swollen and it was huge,), VACCINATION SITE ERYTHEMA (arm stay red and swollen for a quite a few a days) and VACCINATION SITE SWELLING (arm stay red and swollen for a quite a few a days) had resolved.            The patient stated that she was not going to take the second booster because of the side effects caused by the first booster. No treatment medications were reported.
Irregular menstruation. Frequent, heavier, longer periods. First early period began approximately one month after vaccine. Continued frequent periods, up to 5 days apart. Lasting up to 7 days when normally 3-4. Some spotting between periods. No treatment at this time. 5 months of irregular periods at the time of this report.
A report was received from a health care professional on 12/9/03 concerning a group of 5 vaccinees aged between 4 to 9 years old and of unknown gender, who inadvertently received 0.25ml of Fluvirin on an unspecified date in November 2003. On an unspecified date in November 2003, the vaccinees inadvertently received 0.25ml of Fluvirin vaccine. No adverse symptoms had been reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient received the injection of Gardasil and within seconds fainted.  Within a minute the patient was again alert.
Immunizations given 5/3/07 at 130 PM then at 500PM baby was fussy and has some fever. On 5/4 started vomiting a "yellow foamy liquid" and fever 102. Vomited X 4. Taken to ER 7 PM on 5/4. Given Pedialyte through 5/5 at noon. Okay after that.
soreness in his arm; This is a spontaneous report from a contactable consumer. An adult male patient received first single dose of BNT162B2 (Pfizer/BioNTech, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on Jan2021 for COVID-19 immunization. The patient had no relevant medical history. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient reported after his first shot he had soreness in his arm (onset date: Jan2021). The patient was not covid tested post vaccination. The outcome of the event was unknown.  Information on the lot/Batch number has been requested.
Pt recv vax on 9/18/98; on same day pt exp hotness & shaking