chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/10/15 pt received PNEUMOVAX-23 and AFLURIA left arm IM about 2 inches apart around noon. Morning 12/11/15 pt had upon awakening shooting pain down legs, aching buttocks, and difficulty lifting all limbs. Told pt. to seek a doctor visit and called Dr. for follow-up later on 12/11/15. Pt has not seen doctor yet.
Information has been received from a registered nurse concerning a patient of unknown age and gender. On 21-JAN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number not provided), 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested.
Patient was administered a booster dose of Moderna Bivalent vaccine on 8/16/23, however upon a clinic inspection on 8/23/23 it was noticed that the probe wire had been severed and was showing improper read outs.    Upon review that last temp recorded in the correct range had been on 7/26/23 at 1003am.  #1 issue did not alarm as it should have.    After contacting Moderna on 8/23/23 stating that the temp of the vaccine was truly unknown from 7/26/23-8/23/23 and there could have been deviation for >24 hours the stock was deemed unusable and discarded.  When running a report only 1 patient had received the vaccine on 8/16/23.  The patient was contacted and told that guidelines, due to the temp excursion, no harm had come to him however there will be no efficacy of the vaccine and he will need to get a repeat dose as soon as he is able.
diarrhea; weakness; vomiting; shivering/chills 3-4 hours; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ASTHENIA (weakness), VOMITING (vomiting), CHILLS (shivering/chills 3-4 hours) and NAUSEA (nauseous) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (weakness), VOMITING (vomiting), CHILLS (shivering/chills 3-4 hours) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ASTHENIA (weakness), VOMITING (vomiting), CHILLS (shivering/chills 3-4 hours) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Reporter did not allow further contact
Progress Notes  COVID VACCINE CLINIC  Subjective Patient is a 35 y.o. female who was seen at COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and shaking. +Hx of hypoglycemia.  She denied rash, difficulty breathing, difficulty swallowing, wheezing, itching and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , collapse and rapid progression of symptoms.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness   Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing and headaches    +shaking:     Previous Reactions: Became lightheaded after her first dose of COVID vaccine as well.     Objective    Vitals Vitals:   03/22/21 1546 03/22/21 1553 BP: (!) 141/86 (!) 140/101 Pulse: 92   SpO2: 99%        Blood Sugar 104 at 1545.     Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water Follow up response to treatment: good. Lightheadedness and shaking resolved prior to discharge. Pt was escorted out of the facility and denied symptoms while ambulating out.  Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash)   Electronically Signed 3/22/2021 3:54 PM
My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.) 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 RASH (My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.). At the time of the report, RASH (My friend received the primary series of the Moderna Covid-19 vaccine.  My friend has a rash all over her body after receiving the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Drug details were reported.  No Treatment information was provided.
pt diagnosed positive for COVID on 8/24/21; received monoclonal antibody infusion 8/31/21; presented to ED(9/1/21) via EMS for increasing SOB, cough, weakness; O2 sats 75% on RA; Hx of CKD, DM; suffered AKI requiring hemodialysis during his stay; pt's condition worsened; he was made comfort care; died in the hospital
This case was reported by a consumer and described the occurrence of pain in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced pain. It was reported that the Hepatitis B for adults comes in a 1 ml vial and is more painful compared to other vaccines. At the time of reporting the outcome of the pain was unspecified.
Pt was vaccinated at the drive through clinic on 4/23.  When he was asked at our clinic if he received a vaccination within the last 14 days he said "No". Pt was given the vaccine and then resented his vaccination card. The vaccinator realized the 1st dose was only 14 days ago. We referred pt to his PCP
Information has been received from a medical assistant and refers to multiple unknown patients of unknown ages and genders. There was no information about patients' concurrent conditions, medical history or concomitant medications. On multiple unknown dates, since 17-MAY-2017, the patients were most likely vaccinated with doses of improperly stored ROTATEQ lot # M019707 and expiration date of 25-OCT-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 32°Fahrenheit degrees to 35°Fahrenheit degrees for 2 hours and a lowest recorded temperature of 30.2 Fahrenheit degrees for two cycles for a cumulative timeframe of 10 minutes).  No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015824: US-009507513-1706USA001767: US-009507513-1706USA001765:
Dehydrated; achiness; Very tired after getting the first shot; injection site had been kind of achy and sore for 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of DEHYDRATION (Dehydrated), MYALGIA (achiness), VACCINATION SITE PAIN (injection site had been kind of achy and sore for 2 days) and FATIGUE (Very tired after getting the first shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and MINERALS for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site had been kind of achy and sore for 2 days). On 13-Jan-2021, the patient experienced MYALGIA (achiness) and FATIGUE (Very tired after getting the first shot). On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEHYDRATION (Dehydrated). On 14-Jan-2021, VACCINATION SITE PAIN (injection site had been kind of achy and sore for 2 days) had resolved. On 15-Jan-2021, FATIGUE (Very tired after getting the first shot) had resolved. At the time of the report, DEHYDRATION (Dehydrated) and MYALGIA (achiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided. Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-Apr-2021 included second dose vaccine details, AE dehydration updated.; 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.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reaction/allergies were not reported. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK SD-PFS LLok w Tip", 0.5 ml lot # L007720 with expiration date of 08-JUL-2016, 0.5 ml (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 168 hours, with a lowest recorded temperature 1 F (also reported as 1 Celsius degree). There were also another excursion on an unknown date which lasted 96 hours with a lowest recorded temperature of -1 F (also reported as -1 Celsius degree). The vaccine status was reported as "in excursion".  The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Grandma gave him a hot bath in the evening, put lotion on, and he started crying really loudly, he threw his head back and then got very quiet. He seemed to hold his breath for 30 - 45 seconds. Mom said he looked gray. His color returned pretty quickly when the brought him back. Called 911, paramedics checked him out, did not transport.    He seemed to be more sleepy after that. Mom took him to the ER because she was worried about his sleepiness and that she did not think his breathing looked normal.    His temperature has been around 99.9 - 100. His temperature got up to 100.1.
Initial report was received on 01October 2013 from a consumer who is also the patient. A pregnant female patient (date of birth not reported) with a history of allergies to penicillin, sulfa, shellfish and iodine had received at 10 AM on 01 October 2013 at 30 weeks gestation a dose of FLUZONE Quadrivalent (lot number, route and site of administration not reported) and after vaccination while driving to work at 1130 AM on 01 October 2013, experienced difficulty breathing, throat feeling dry and coughing. The reporter also stated that her baby's heart rate was elevated (captured in case 2013SA100444). The patient was treated in the emergency room with prednisone, BENADRYL and oxygen. The patient stated that about one hour later the symptoms cleared. The patient continued on prednisone and BENADRYL for three days. The outcome was reported as not recovered. Documents held by sender: none. After internal review on 04-NOV-2013, a significant corrective version with date of the previous version i.e. 02-OCT-2013 was created to change the suspect product from Influenza quadrival thiomersal free vaccine (manufacturer Sanofi Pasteur SA) to Influenza Quadrival A-B vaccine (manufacturer Sanofi Pasteur Inc.).
Information has been received from a healthcare worker (also reported as medical assistant (M.A.)) referring to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (lot # and dose not reported). Information regarding concomitant medications was not reported. No adverse effect reported. The outcome of the event was unknown. There was no product quality complaint involved. All telephone attempts on 10-AUG-2015 to obtain follow-up information have been unsuccessful. This is one of the two reports received from the same reporter. Additional information has been requested.
Chills, headache, threw up, nausea, body aches, exhausted feeling. Started around 3 am the morning after the vaccine. Lasted all day/night. Woke up the 25th with a headache and felt run down. Both were better by the afternoon
Headache  Fever Loss of Appetite  Lethargic  Neausea Swelling at injection site Pain at injection site
Case number PHEH2012US016072 is an initial spontaneous report received from a nurse on 09 Aug 2012. This report refers to an unknown age group and gender. This patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on 09 Aug 2012. No other adverse reaction was reported following this administration error.
Onset the next day w/ low grade fever,  cough, extreme fatigue, HA. Symptoms persisted, plus suppressed appetite.  Came to our office for appt on 3/29 /21 and was sent to ER with SaO2 of 84%. Inpatient from 3/29/21 to 4/1/21. Treated for acute respiratory failure, "covid pneumonia" secondary to covid. Treated with Remdesivir, dexamethasone, lovenox,  and azithromycin. Azith was discontinued because they thought the pna was viral rather than bacterial. She was discharged home on BID albuterol, a medrol dosepak and continuous oxygen at 2LPM. Pt was told that they suspected she had asymptomatic covid prior to vaccination.  Her symptoms improved and she discontinued daytime oxygen on 5/17/21 , but night time O2 was still indicated.  By  6/29/21 she felt she was back to baseline with the exception of nocturnal hypoxia. As of today, 9/24/21, she remains on supplemental night time oxygen. Nocturnal oximetry is pending.
I got the shot on 1/23/21.  The symptoms began on 1/29/21.  I broke out in hives, then I sufferered flu like symptoms with high fevers (101.5), body aches, pains, no energy, hives on my chest and back that were both itchy and painful.  Foggy in the head, no energy, unable to sit up for long periods of time.  Never felt so sick in my life.
Approximately 4 minutes after the injection, while sitting down, I felt light headed, sweating, weak, face turned white. I was close to passing out but didn't. I requested attention after about 10 minutes. While being treated by medics they mentioned color had returned to my face. I felt better enough so I refused to go to hospital and was driven home. Later that morning, 03/08/2021 about 10 AM, I developed a fever and body aches with sharp pains thru out my body and joints. First temperature check was 100.5. My fever, pains/weakness increased thru out that day and overnight with chills. Highest temp check was 102.8 that evening prior to bedtime. I don't know if it could have been higher at some point overnight. It felt like I had a moderate to bad case of the FLU. The next morning, 03/09/2021 the fever broke down to about 101. By 03/11/2021, aside from a little residual weakness I felt more like myself. However, as of the writing of this report my temp seems to fluctuate between normal and 99.8. Will report this to my Doctor on next visit. Worth noting that I haven't had any Flu like symptoms to that degree in many years.
Patient had onset of pleuritic chest pain on 11Dec09, 9 days after  administration of the small pox vaccine.  Peak troponin I was about 4.  His echo was normal and he responded well to indocin
suspected vaccination failure/he 2 shots and still got a mild case of Shingles; shingles; just the pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient was vaccinated with the two doses of Shingles vaccine and still got a mild case of shingles and did not experienced rash, but pain was there. The follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Red rash on inner arms, top of legs and stomach; Tingling; Very irritating; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CSHDER8731), via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have a history of allergies to any food or medications or other products. Concomitant medications included acetylsalicylic acid; caffeine; salicylamide (EXCEDRIN), paracetamol; pseudoephedrine hydrochloride (TYLENOL SINUS), loratadine (CLARITIN) and gummy vitamin (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CSHDER8731), via an unspecified route of administration in the right arm on an unknown date at 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 12:00 (day of second shot), the patient experienced a red rash on inner arms, top of legs and stomach, tingling and very irritating when used the tanning bed. No therapeutic measures were taken for the events. The clinical outcome of the events red rash on inner arms top of legs and stomach, tingling and very irritating were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received varivax yesterday morning at 10AM. At 2pm she developed fever to 100.4F. Mother gave her some tylenol. At 4pm, patient developed an itchy rash (hives) diffuse. Mother has been giving tylenol every four hours. Highest temp was 100.9F at 1am today. Patient did not have any new food exposures that afternoon (carrots, potatoes, ham, green beans, salmon). She had slight sore throat since this morning (no complaints yesterday). She is not receiving any additional medication. No headaches. No N/V/abd pain. She does have some diarrhea (2 BMs today without blood or mucus; stool is real "watery"). No other sick contacts. Patient was not in school since Wednesday of last week. No difficulty breathing or facial or tongue swelling. She has not been taking her claritin.  Of note, patient was seen on 12/10 for a history of right red eye then bilateral red eyes on wednesday (12/6) which resolved over the next two days. It was definitely resolved at her visit on 12/10. Pt with slight sore throat since Wed night (12/6). Fever on Thurs (12/7) to 101F which resolved. She was noted to be eating less but taking fluids well with recent void. No vomiting. No rash. Patient with hx of periumbilcal pain for the past two months with hx of constipation. Last BM was wednesday (12/6) followed by BM on saturday (12/8). On saturday (12/8) her bowel movement was "hard." No blood in the stool. Mother does not note an association of abd pain with meals or types of foods. No tenesmus. No change in abdominal pain with defecation. No dysuria, frequency, or urgency. No hx of UTIs. Mother has tried heating pads with some relief. She has not tried any OTC antacids. No OTC analgesics.
swelling face; swelling arm of injection; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (swelling face) and VACCINATION SITE SWELLING (swelling arm of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (swelling face) and VACCINATION SITE SWELLING (swelling arm of injection). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swelling face) and VACCINATION SITE SWELLING (swelling arm of injection) 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 concomitants were reported.   This case was linked to MOD-2021-020217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received on 22-May-2021 contains non significant information, response to ADR. Unable to identify patient. Reporter address updated. On 24-May-2021: Follow up received on 24-May-2021 contains no new information; Reporter'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.