chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu; sick; Initial information was received on 16-Feb-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via media.  This case involves female patient (age not specified) who had flu (influenza), while she received INFLUENZA VACCINE.  The patient's past vaccination(s) included influenza vaccine in 1973 with first shot as sick for prophylactic vaccination.  Past medical treatment(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in 1975, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (sickness) hours after each shot and Flu (influenza) (serious, unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events.  It was unknown if the patient experienced any additional symptoms/events.  Patient vowed never again will I take it.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of events were unknown.; Sender's Comments: This case concerns female patient who had influenza and their symptom sickness after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
General body aches, fever, neck stiffness malaise - 10cmx15cm of redness swelling of LD site vaccine given.
Moderna COVID-19 Vaccine EUA.  I had Covid-19 in  March 16,2020.  24 hours post vaccination,  I am experiencing exactly same symptoms as when I was sick with  Covid-19. Symptoms started exactly 22 hours after I recevied the vaccine.  Symptoms/ Side effects :  Fever, highest so far 100.8, chills, malaise, headache, diarrhea , runny nose, nasal congestion,  overall an unwell feeling
vaccine expiration date. it appears that vaccine was given 3 days after expiration date; No adverse reaction after vaccination
Redness, swelling, pain at area of injection extending down left arm. Dx Cellulitis.
Redness at injection site, soreness, warmth, itchiness. Presumed cellulitis vs allergic reaction to vaccine.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 12:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 12:31 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 84.60 years. Concomitant products were not reported. Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit and 35 degrees Fahrenheit from 09 AM to 2 PM. This vial was moved to fridge on 05-Jan-2021 and 08-Jan-2021, also beyond use date for the vial was reported as 04-Feb-2021 and 07-Feb-2021. Product moved to clinic on 08-Jan-2021 and 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Next day both hands swelled & had rash on forearms.  Rash present second day.  Seen at doctor 12/2/09; given Benadryl.  On 12/3/09 reports pain in arm.
Nausea, headache, muscle aches for 48 hours.  Fever of 100.4 for 24 hours.  On third day following the vaccine, a raised rash fom shoulder to elbow on right arm with feverish feel.  Rash end after two days.
Patient passed out and looked like she was seizing for about 5 seconds. She then came to and was sweaty. 911 was called and arrived at 11:40 am. Her vitals were checked. She did not want to go to ER. She stayed seated at the pharmacy until a friend came to pick her up.
Patient stated she felt a sensation from the area of the injection traveling to her wrist. She stated it was swollen and feeling tight. Her blood pressure was taken at 1600: 144/94. Her heart rate was also elevated. RN on site, applied a cold compress to the wrist. Patient held it against her wrist for 20 minutes. At 1620, she felt better and calm.  She return to work and her duties.
1527 employee was administered varicella #1 on left SQ/upper arm, patient immediately complained of pain in arm but stated she felt fine. 1528 employee was administered MMR #2 on right SQ/upper arm and immediately complained of pain, I asked if she felt okay and explained signs and symptoms of anaphylaxis reactions and asked if she was experiencing any of them. she asked for a cup of water and stated she felt as if she couldn't swallow.  I grabbed a nurse and proceeded to give her water as requested.  Nurse tried getting BP but was unsuccessful with reading so we immediatly helped her into a wheelchair and rushed her straight to ED. 1340-1345 the employee checked into ED and proceeded explanation of symptoms she was experiencing.  She began to go into detail about possibly having previous reaction as a small child and being hesitant to receive 2nd MMR.  As she continues to slowly sip water, she states her throat felt tight as if she had to burp or something would possibly come up.  She states she felt a knot, ball, or lump in her throat.  She also stated moreso on left side of throat/neck area, she felt tightness..she goes on to say  "something just isn't right".
Night of vaccine: sore arm, severe headache, dizziness, low grade fever (99), chills. Recovered the following afternoon. One week after vaccine developed tingling in left leg, two weeks after vaccine developed mild numbness/loss of sensation on left side. Went to urgent care and then to ER, they suspected complex migraine as I have a history of migraine (though had never had one lasting that long). Numbness has been intermittent since but seems to have mostly gone away.
Redness and swelling 9-10 cm diameter around injection site. Treatment: Ice, ADVIL, BENADRYL.
Information has been received from a physician concerning a infant male with no medical history who in January 2007, was vaccinated with a dose of Rotateq. There was no concomitant medication. Within one week of vaccination, in January 2007, the patient started to have "a lot of eczema". He was then switched over to formula. The infant had been breastfeeding for 11 weeks prior to formula switch. "All of the sudden" the infant was up all night crying. The formula was change three times. The infant was seen by the physician on 16-MAR-2007 and had a number of blood tests done. An IgG showed 35, and the patient was diagnosed with hypogammaglobulinemia. The infant also was diagnosed with lymphocytosis. The patient's mother was tested to see if the condition was genetically related. The mother's test were normal. The infant requires infusion of gamma globulin. The infant was hospitalized. It was reported that failure to thrive was considered to be disabling. There was no product quality complaint involved.
Received 1st dose on 1/16/21. 7 days after 1st Moderna dose (1/22/21)  left arm (where injection occurred) arm started to itch. Day 8 arm was swollen/welts, red, hot, itchy. Day 9 area of allergic reaction doubled. Took Benadryl. Helped with itchy feeling. Day 10 (1/25/21) woke up and reaction was larger. Approximately 14 cm. by 12 cm. Went to doctor as pharmacist who suggested Benadryl was unsure if allergic reaction to Moderna or perhaps the injection needle. Doctor prescribed antibiotic and ointment because he had not heard of a delayed onset reaction like this. Started antibiotic/ointment combo Monday, 1/25/21. A little better, not much. Writing this on the evening of 1/28/21. Tomorrow will be 1 week of reaction
first dose of the Shingrix vaccine in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, wich led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021218230, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218230:same reporter
advanced difficulty in breathing; intense dysphoria when breathing; had a hard time standing; pain in the back; slight reduction in the wheezes in his left lung; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (advanced difficulty in breathing), DYSPHORIA (intense dysphoria when breathing), PAIN (had a hard time standing), BACK PAIN (pain in the back) and WHEEZING (slight reduction in the wheezes in his left lung) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included Lobivon                                                        Nebivolol, Triatec-plus                                                   Ramipril/Hydrochlorothiazide, Salospir                                                       Acetylsalicylic acid, Zocor                                                          Simvastatin, Omnic-tocas                                                    Tamsulosin, Zyloric                                                        Allopurinol, Lobivon                                                        Nebivolol, Triatec-plus                                                   Ramipril/Hydrochlorothiazide, Salospir                                                       Acetylsalicylic acid, Zocor                                                          Simvastatin, Omnic-tocas                                                    Tamsulosin and Zyloric                                                        Allopurinol for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (advanced difficulty in breathing), DYSPHORIA (intense dysphoria when breathing), PAIN (had a hard time standing), BACK PAIN (pain in the back) and WHEEZING (slight reduction in the wheezes in his left lung). On 25-Mar-2021, DYSPNOEA (advanced difficulty in breathing), DYSPHORIA (intense dysphoria when breathing), PAIN (had a hard time standing), BACK PAIN (pain in the back) and WHEEZING (slight reduction in the wheezes in his left lung) had resolved. Not Provided      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.
This spontaneous report was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M018767 (expiration date 01-FEB-2017) and lot # M022531 (expiration date 23-FEB-2018), (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Pt began feeling lightheaded after receiving her vaccine. Medical staff was notified and witnessed a syncopal episode where pt was seen with flexed arms and bladder incontinence. Pt was AOx4 after regaining consciousness with SBP in the 80s, diaphoresis, and nausea. Pt did report history of syncopal events associated with needles and SBP around 90s. Pt was monitored  and later released by medical staff and EMS after symptoms resolved. PT was instructed to follow up with PCM regarding possible concerns for seizures and hypotension.
really sick; leg really hurt bad; HIGH FEVER; feeling exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really sick), PAIN IN EXTREMITY (leg really hurt bad), PYREXIA (HIGH FEVER) and FATIGUE (feeling exhausted) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 07-Dec-2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION COMPLICATION (really sick), PAIN IN EXTREMITY (leg really hurt bad), PYREXIA (HIGH FEVER) and FATIGUE (feeling exhausted). At the time of the report, VACCINATION COMPLICATION (really sick), PAIN IN EXTREMITY (leg really hurt bad), PYREXIA (HIGH FEVER) and FATIGUE (feeling exhausted) 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.   No relevant concomitant medications were reported.  Treatment details included Ibuprofen and Tylenol.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd vax;devel fever of 104;tx w/ acetaminophen;fever persisted throughout the noc;red blotches present around inject site;c/o tenderness around inject site & pain; did not walk for several days;30nov94 sxs resolved;
Was up all night; Could hardly walk; Acid reflux; Felt very sick; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Was up all night), GAIT DISTURBANCE (Could hardly walk), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), ILLNESS (Felt very sick) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INSOMNIA (Was up all night), GAIT DISTURBANCE (Could hardly walk), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), ILLNESS (Felt very sick), HEADACHE (Headache) and MYALGIA (Body aches). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, INSOMNIA (Was up all night), GAIT DISTURBANCE (Could hardly walk), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), ILLNESS (Felt very sick), HEADACHE (Headache) and MYALGIA (Body aches) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUN-2021. Reporter stated that they are fine now and denied for further follow-up.
pt recv vax & approx 9 days p/vax pt exp a high fever;it was reported that pt then devel other complications including a dec in WBC count thrombocytopenia & leukopenia as well as elevated LDH enzyme levels;pt hosp;
I began developing an itchy rash on day 10 similar to hives.  I still have it and it has increased from a small location to all over my body.
Vaccination may have been given in wrong part of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination may have been given in wrong part of the arm) in a patient of an unknown age and gender 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 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination may have been given in wrong part of the arm). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination may have been given in wrong part of the arm) had resolved.            No concomitant medications were provided. No treatment medications were provided.
After receiving covid vaccine, patient reported chest pain, tachycardia. Chest pain occurred in conjunction with back pain in between shoulderblades.  Pain described as pressure.   Also occurred after initial Pfzier vaccine Lot # EWO182 administered 9/15/21 and lasted for 2 weeks. Heart rate remained over 100.  Drinks 1 caffeinated beverage per day. Both instances were also associated with intermittent shortness of breath.
No symptoms until the following early morning hours. Woke up extremely sore at injection site. Pain rapidly got worse and spread throughout body as day progressed. Ears started ringing, and got very dizzy mid morning, also experienced odd, shaky movements in vision. Developed a fever towards the evening, fever continued to spike up to 103.1. Developed a severe headache, along with great difficulty moving due to severe pain throughout entire upper body. Felt pain and pressure in my spine. Fever broke and spiked several times throughout the night.  Day 3: Still extremely sore, headache, jaw pain, mild fever on and off.
Prior to my second Moderna vaccine I had a mild, localized case of granuloma annulare that was present mostly on my thighs and legs.    A few weeks after the  2nd moderna vaccine my granuloma annulare became generalized and spread to my arms, trunk, neck and is covering my entire back.
Injection site discomfort; Dizziness; Burning sensation behind eyes; Ocular migraine; Vision difficulty; Bladder spasms and urgency; Cognitive fog worsened.; Fever; Chills; Arthralgia; Fatigue; Headache; Myalgia; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE DISCOMFORT (Injection site discomfort), DIZZINESS (Dizziness), EYE IRRITATION (Burning sensation behind eyes), OPHTHALMIC MIGRAINE (Ocular migraine) and VISUAL IMPAIRMENT (Vision difficulty) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 026L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, METOPROLOL SUCCINATE (TOPROL XL) and HYDROCHLOROTHIAZIDE for Hypertension.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (Injection site discomfort), DIZZINESS (Dizziness), EYE IRRITATION (Burning sensation behind eyes), OPHTHALMIC MIGRAINE (Ocular migraine), VISUAL IMPAIRMENT (Vision difficulty), BLADDER DISCOMFORT (Bladder spasms and urgency), CONDITION AGGRAVATED (Cognitive fog worsened.), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Myalgia) and NAUSEA (Nausea). At the time of the report, INJECTION SITE DISCOMFORT (Injection site discomfort), DIZZINESS (Dizziness), EYE IRRITATION (Burning sensation behind eyes), OPHTHALMIC MIGRAINE (Ocular migraine), VISUAL IMPAIRMENT (Vision difficulty), BLADDER DISCOMFORT (Bladder spasms and urgency), CONDITION AGGRAVATED (Cognitive fog worsened.), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Myalgia) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were provided.   This case was linked to MOD-2021-011802 (Patient Link).
Two days after getting the vaccine, I got terrible joint pain in all of my joints. I also got a bladder infection that I still have. I also have skin hives, like welts, all over my back, chest and arms. I have had a lot of headaches and I am tired all of the time. I have seen Dr. on multiple occasions since receiving the vaccine, nothing has helped any of my symptoms. He did try to give me steroids and 2-3 different antibiotics for my bladder infection. I was then send to Dr. would looked into my bladder, seeing something black. The did a biopsy on my bladder.
A non-serious, spontaneous report of fever and chills has been received from a consumer concerning a 5-year-old male, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 01-Oct-2009. On the same date, the patient experienced fever and chills. The events of fever and chills are ongoing.
Donor states 2-3 days post immunization had moderate itching intermittently at injection site, lasting approx. 2 days.
1st Dose 012-L20A    This is when the rash may have begun.  I t was minor and very slow spreading.  The second dose caused the rash to spread quicker and noticeably visible raised rash which was not reactive to prescription steroidal creams.  it also became itchy.  I wish I have made the link to the vaccine earlier.  Other than this I was symptom free and so pleased that I could tell everyone I had no problems.