chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper respiratory infection; exacerbated asthma/Asthma worsened / could not breathe at night; Achy joints; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection), ASTHMA (exacerbated asthma/Asthma worsened / could not breathe at night), ARTHRALGIA (Achy joints) and FATIGUE (Fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 1979, Disability and Fibromyalgia.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRALGIA (Achy joints) and FATIGUE (Fatigue). On 09-Apr-2021, the patient experienced ASTHMA (exacerbated asthma/Asthma worsened / could not breathe at night). On 20-Apr-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). The patient was treated with AZITHROMYCIN on 20-Apr-2021 for Upper respiratory infection, at an unspecified dose and frequency and PREDNISONE for Asthma aggravated, at an unspecified dose and frequency. On 09-Apr-2021, ARTHRALGIA (Achy joints) and FATIGUE (Fatigue) had resolved. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) and ASTHMA (exacerbated asthma/Asthma worsened / could not breathe at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On Friday, 09-Apr-2021, asthma worsened and the patient was prescribed prednisone. The patient had asthma since 12 years of age but never to the extent where she could not breathe at night. She reported using a nebulizer.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Added event (upper respiratory infection) and treatment drug (azithromycin).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
The evening of the day that I received the 2nd Jaasen (Johnson & Johnson) vaccination it felt like my heart was skipping beats... I had arrythmia.  I went to the doctor the next day and reported it again. I was sent to a Cardiologist and they verified that I had 12000 extra heart beats per 24 hours. They tried to increase carvedilol  and other heart drugs but I broke into hives for 10 days. Here I am a year and a half later 1/22/2023 and it feels like every 5th beat is missing. In actuality, I am have PVC's still.  Are there any other cases like mine and what can be done to help th
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 11 week old patient who was vaccinated on 05-DEC-2022 with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023, orally (PO). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Client c/o seeing bright light immediately after receiving the vaccine.  Client states that she did not experience any symptoms c the first dose.  Client seen and assessed by paramedics and vital signs are BP 110/60, O2 97, HR-82.  Within 15 min. of observation client verbalized that she no longer felt symptoms and was cleared to go home by paramedics.
5-10 min after receiving vaccines, pt felt faint, dizziness. Pt sitting in hallway near office sweating. Pt escorted back to office. Vital signs stable. Pt was observed in office 30-45 min and released home with parent. Instructed to go to ER if symptoms return.
Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days; She experienced a delayed allergic reaction; Patient developed shortness of breath; wheezing; full body rash; hives; itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days), HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing) and RASH (full body rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days), HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing), RASH (full body rash), the first episode of URTICARIA (hives), PRURITUS (itching) and the second episode of URTICARIA (hives). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days) had resolved and HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing), RASH (full body rash), PRURITUS (itching) and the last episode of URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided by the reporter.
pt tolerated vaccine well.  7/1 pt had uri symtoms after exposure to family member with + covid.
Diarrhea with blood; Headache; Insomnia; A spontaneous report was received from a 63-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea with blood, headache, and insomnia.  The patient's medical history was not included. Concomitant medications were not reported.  On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 012L20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 07 Jan 2021, the patient experienced diarrhea with blood, headache, and insomnia for couple days.   Treatment included aspirin for the headache after 3-4 days from getting the vaccine.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, diarrhea with blood was resolved on 08 Jan 2021 and the outcome of the events insomnia and headache was resolved on unknown dates.  ; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous initial report was received from a nurse referring to a patient with age and gender unknown. Patient medical history, concurrent conditions and concomitant medications were not reported. The nurse informed that on 15-JUN-2017 the patient was vaccinated with a first dose of M-M-R II (strength and dose unknown) subcutaneously, lot # M017346, albumin status reported as rHA (recombinant human albumin), indicated for prophylaxis. The nurse also reported that on 14-SEP-2017, 3 months after the first dose of M-M-R II, the patient inadvertently received a second dose of M-M-R II. No adverse event was reported.
Patient was 16 years old and given first dose Moderna vaccine. There were no symptoms or adverse events.
States face tingle, legs weak, light headed.  BP 138/80 AP 100 OT 97.8 given fluids monitored. 12:15 BP 130/80 AP 80 Lungs clear, not SOB, no swelling at site oriented X3. 12:40 Improved feeling of light headedness no SOB.
Initial and follow up spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Since an unspecified date in February 2014 the unspecified number of patients might have been administered improperly stored doses of (Oka/Merck) VARIVAX (lot # unspecified) (dose, frequency, route and location unspecified). No adverse events were reported. Initial was made regarding improperly report vaccine where no AE was indicated. Follow up information had been received stating that (Oka/Merck) VARIVAX was administered.  Additional information has been requested.
a warm and thirsty throat; a warm and thirsty throat; dizziness; nausea; pain around spleen; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EN6206) via an unspecified route of administration administered in Arm Left on 10Mar2021 09:30 (at the age of 53-years-old) as single dose for covid-19 immunization. The patient's medical history included thyroid cancer, chronic back pain, thoracic carcinoid and known allergy to green vegetables and some type of MRI or CT Contrast. The patient's concomitant medications included levothyroxine at 100 mg. On 10Mar2021 at 09:45, after been vaccinated patient started having a warm and thirsty throat. Within next hour, started feeling severe dizziness, nausea and pain around spleen. Next, the patient started feeling tiredness and weakness. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Hospital ER- admitted   one night overnight obsevation  AT 3:00 pm  notice feeling faint, anxious,  heart rate bouncing from 45- 140 at rest, for hour or more, then 140  continuous, primary doctor office said to go to ER- hyperthyroidism noted in blood work Seen and treated by 9 pm  -      second ER visit 5/10/2021  same symptoms  after second dose on 4/28/2021 at 1 pm  12 days after shot  went back in to sinus rhytmn after arriving at ER hospital 3 hours post symptoms starting currently then on oral diltiaen 120 Cp24-sent home  again hyperthyroidism noted in bloodwork
Experienced increased breathing problems which started the evening of the next day.  Had experienced this before after tasking medication as reacts to alot of things.  This time did not improve and so went to personal dr one week later and was put on oxygen 2 liters continually due to low oxygen stats.  Remains on oxygen 2 liters now.
Information has been received from a health professional concerning a patient (11 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
After initial soreness at shot sight wore off, pain in shoulder and elbow began to increase.  It seems to be a rheumatoid arthritis flare up (or something like it) that had NEVER occurred before.  It has now been 15 days of pain.
received only the adjuvant component; received only the adjuvant component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 3BD53, expiry date 7th July 2023) for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Shingrix. On 8th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 08 July 2022 Reporter's Comments:  The reporter stated patient received only the adjuvant component of the vaccine. The patient was monitored for 2 hours and there were no reactions. The reporter consented to follow up. Additional supportive information As patient received only adjuvant component of the vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient was given flu vaccine at primary care office earlier in day then seen in the emergency department for injection side redness, swelling, hardness and pain. Patient given Prednisolone, BENADRYL and TRIMOX in ER. Patient was discharged and mother instructed to follow up with primary care.
chills; nausea; chest congestion; nasal congestion; diarrhea; cough; body aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration, administered in Arm Left on 21May2021 09:30 (at the age of 38-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included thrombosis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported that prior to four weeks of vaccination patient not received any other vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received medication Inflamma-Less by Irwin Naturals with in two weeks of vaccination. On 26May2021 8:00 patient experienced symptoms exactly 5 days after that includes but was not limited to nausea, chest congestion, nasal congestion, diarrhea, cough, body aches and chills. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623501 same reporter, vaccine and AE, different patient.
Pt recvd Engerix-B 19JUL91, 21AUG91 & in AUG or SEP91 exp onset of inc liver enzymes;
Injection made approximately 8:50 am Friday 7/31.  Redness, pain and swelling began several hours later.  Had trouble sleeping Friday night.  Woke up with headache on Saturday morning.  Headache lasted 2 days.  Extreme fatigue all day Saturday and most of the day Sunday.  Hot flashes made me feel like I had a fever, but temperature was taken twice on Saturday and it was normal.  Unable to do normal daily activities Saturday and Sunday.
Information has been received from a health professional concerning a 5 year old white female with a peanut allergy who on 01-APR-2003 was vaccinated in the right lower arm with a first dose of Varivax (lot # 641787/0758M) (diluent lot # 638153/0886M). There was no illness at the time of vaccination. On 10-OCT-2006 the patient presented to the office with an outbreak of chickenpox, the actual onset date was not reported. At the time of the report the patient's recovery status was unknown. No further information was available. Additional information has been requested. The patient's brother (WAES # 0610USA10411) had a similar experience after vaccination.
A physician reported that a 2 month old infant developed hives following  immunization with Prevnar (dose 1). The infant had no difficulty breathing and did recover. No further information was provided. *See HQ8984029NOV2001 for information regarding a subsequent report of hives. FOLLOW-UP information received on 12/20/2001: Prevnar was administered on 07/19/01. The event occurred on 07/23/01. The infant received IPV, Hib and DTaP vaccines (manufacturer unknown) on 06/19/01. The male infant's date of birth was 04/05/01
Patient has a very very big rash its just growing its all over her back or her bottom, her arm and her hand; break into hives; This is a spontaneous report from a contactable nurse or other hcp (parent). A 17-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (at the age of 17-years-old) as single dose for covid-19 immunization. Reporter stated regarding first dose date as there was about 4 to 6 weeks ago. The patient's medical history was not reported. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. It was reported that its not helping, getting worse. On unspecified date 4 weeks ago, patient has a very big rash it's just growing it's all over her back or her bottom, her arm and her hand. Reporter stated that patient taken allegra but It's not getting any better we haven't she was never had a rash like this and also experienced hives on unspecified date in 2021. Consumer stated, she has 2 questions both mother and daughter have a very big rash on their back and is spreading to her bottom 4 weeks ago and they were supposed to get the second dose both. she guesses it has been about seven weeks then they have a very big rash. Further reporter stated, they will get second one but if she has this bad over result from it they would want me to DCA write right now until they should know what going on. She is having second dosages and she had all this fever and all that from the beginning of the first dose but now what we just break into hives mother and daughter, she has been on quinidine and everything shall three weeks. Reporter stated, yes please they probably call her because reporter want to know if they want to give the second one because I am still for the second one because it's been about 6 weeks. The outcome of the event hives was not recovered, and the outcome of event patient has a very big rash it's just growing it's all over her back or her bottom, her arm and her hand was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101015552 (same reporter, different patient, parent case)
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 54-year-old male patient who received SHINGRIX for prophylaxis. On 3rd November 2018 17:00, the patient received the 1st dose of SHINGRIX. On 3rd November 2018 21:00, 4 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporting nurse's husband got the dose of SHINGRIX, at around 5 PM and by 9 PM he had redness, swelling, heat and tenderness at the injections site. The reporting nurse consented to be followed up.
This spontaneous report as received from a registered nurse refers to a 18-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On an unknown dates in 2015, the patient completed the vaccination schedule with three doses of GARDASIL 9 (exact dose, route of administration, injection site, lot# and expiration date were not provided), for prophylaxis. On 14-MAR-2019, the patient was vaccinated with fourth dose of GARDASIL 9 (lot# R020947, expiration date: 04-MAY-2019), (exact dose, route of administration and injection site were not reported), for prophylaxis. There were no adverse effects.
pt recv vax 10AM & return @ 10:30 pale, itching, sl wheezing, swelling feet & hands;epi, prelone, DPH & claritin given;
Pt developed rash on leg on 29MAY91, feverish, fussy for few days-seen in ER & had red ear & sore throat; dx poss chickenpox; tonsillitis; Later seen by Pediatrician-questionable chickenpox-not definite;
Headache, Myalgia, Arthralgia, Fever, Fatigue, sore thorat Narrative:
(No strength), hives in the face, dizziness, accelerated heart beats. These events started the next day after the administration of the vaccine, Sunday 19 of May of 2013 in the afternoon.  To this day, I have not been able to get a general doctor. Tachycardia continues.
having trouble even walking, I need to walk with a cane; pretty bad reactions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (having trouble even walking, I need to walk with a cane) and VACCINATION COMPLICATION (pretty bad reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (having trouble even walking, I need to walk with a cane) and VACCINATION COMPLICATION (pretty bad reactions). At the time of the report, GAIT DISTURBANCE (having trouble even walking, I need to walk with a cane) and VACCINATION COMPLICATION (pretty bad reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported. Patient reported that " I am still going to ER (Emergency Room) and doctors to figure out what's going on because I was fine until I had Vaccine."