chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was 10 am, temperature was 35, total 117 doses were administered for that day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 05-Oct-2021 and moved to clinic on 03-Nov-2021. 06 vials were sent to the clinic. BUD date was 05-Nov-2021. Vials only punctured right before administration.  Vial was stored on cooler 1, on 22-Oct-2021, Excursion duration At 8 AM: 32, 9 AM: 32 and 10 AM: 32.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Chills; Dizziness; Headache; Stomach Ache; Threw Up Bile; This case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received on an unknown date).   On 1st October 2020, the patient received the 2nd dose of Shingrix. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced chills, dizziness, headache, stomach pain and bilious vomiting. On an unknown date, the outcome of the chills, dizziness, headache, stomach pain and bilious vomiting were not recovered/not resolved.   It was unknown if the reporter considered the chills, dizziness, headache, stomach pain and bilious vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller stated that after received dose of Shingrix, later that night she reported having chills, headache, dizziness, stomach aches, and throwing up bile.  The reporter wanted to know if these side effects were contagious.  The reporter stated that the side effects were going away but that she still had them.  The reporter stated she would get in touch with her HCP. The reporter did not consent to follow-up.
7 days after flu mist pt diagnosed with right middle and right lower lobe pneumonia with effusion.
Extremely tired and sleepy, feverish, sore, red swollen, inflamed.
Date of Admission: 10/10/2022   Date of Discharge: 10/14/2022   Admission Diagnosis: COVID-19 virus infection [U07.1] Iron deficiency anemia lymphoma   Hospital Principal Problem (Discharge Diagnoses): COVID-19 virus infection
I have been post menopausal since July 2020.  Just over 1 week after the vaccine I had a 4 day mini-period.  I was surprised but didn't link it to the vaccine or have a lot of concern. When I visited my PCP for an annual physical in June, I mentioned it to her. She was concerned about it enough to order a transvaginal ultrasound to make sure nothing was wrong. The ultrasound was normal and confirmed I am post menopausal.  In reading about other people's experiences, I learned that breakthrough bleeding and periods for women many years in menopause was occurring. Oddly, in a doctor visit my 19 year old daughter also mentioned having an unusual period mid-cycle in the month following her vaccination.
Patient is 16 years of age.  Moderna is not approved for those under 18.  Patient was inadvertently vaccinated at a mass vax event.
7 days after the vaccine, the L upper arm started severely itching, was noticeably swollen, hot and tender to touch.  This lasted 24 hours.   I took a Benadryl and used ice on the L shoulder to get to sleep, Advil the next day, then Benadryl again the next night.  I even used some Cortaid to help the itching.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 10:42, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
severe sweats; Lots of myalgias; headache; Felt febrile; shaking chills; prodrome to a minor respiratory illness; stuffy nose; Initial information was regarding an unsolicited valid non serious case was received from a physician (Reference number- 00800817) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 59-years-old male patient who experienced serious prodrome to a minor respiratory illness (respiratory disorder), severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment included TOZINAMERAN.  The patient's past vaccination(s) included INFLUENZA VACCINES and COVID-19 VACCINE.  The patient's medical history, concomitant medication and family history were not provided.   On 05-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, Suspension for injection, lot number and expiry date not reported) via an unknown route in the left deltoid for prophylactic vaccination.  On 05-Oct-2021, the patient developed non-serious prodrome to a minor respiratory illness (respiratory disorder) and stuffy nose (nasal congestion) (same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 06-Oct-2021, the patient developed non-serious severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included:  SARS-CoV-2 test (severe acute respiratory syndrome coronavirus)- On 05-Oct-2021: Negative  It was not reported if the patient received any corrective treatment for the events.  It was reported "about 6 hours after receiving his flu shot yesterday, he experienced a stuffy nose that seemed like a prodrome to a minor respiratory illness. He went to bed and woke up around 02:00 with severe sweats, shaking chills, lots of myalgias, headache, and felt febrile. He believes the symptoms are related to the flu shot, but it seems very peculiar to him since he has not experienced reactions to flu shots before now. He said, I thought that this seemed like a robust reaction to a flu vaccine. He now feels fine".  On an unknown date, the patient was recovered from the events.  There will be no information available on the batch number for this case.
Red, swollen, hard lump. Patient was taken to the MD and MD stated it was cellulitis. Patient is now on steroids and antibiotics.
Pt was given a Quadracel by an RN. Pt is 7yo and is outside of the recommended range for this combination vaccine.  Next day after vaccination Pt did have headache, arm pain, low grade fever, and some mild swelling at injection site.
OVERALL  ACHINESS IN UPPER BODY; LABORED BREATHING; EXTREME PAIN IN JOINTS/PAIN IN RIGHT WRIST/SHOULDER PAIN/ELBOW PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180869 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced overall achiness in upper body. On 03-APR-2021, the subject experienced labored breathing. On 03-APR-2021, the subject experienced extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labored breathing, overall achiness in upper body, and extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
feel flushed, warm all over, itchy, and an urticarial rash  appeared on her upper chest and arms..  given diphenhydramine 50mg IM x1, methylprednisolone 125mg, famotidine 20mg. felt better and all symptoms improved except for pruritis by 1715 on 12/23. discharged home from emergency room
Low grade fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient herself). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0196, Expiry Date: Unknown) via an unspecified route of administration in left arm on 29Jun2021 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization. Patient medical history included osteomyelitis bacterial (E coli infection in titanium rods in lumbar spine, prior to vaccine, diagnosed in OCT 2010) from Oct2010 and ongoing. The concomitant medications were not reported. The patient experienced low grade fever on 07Jul2021 (reported as this morning). The report is not related to a study or programme. No investigation assessment done. she wanted to know if it is possible for the fever to come a week after the vaccination. Patient is asking is this be a side effect of the Pfizer vaccine. States the low-grade fever has started today, states it has been up and down today but is persisting. The clinical outcome of the event low grade fever was not recovered.  Follow-up attempts are completed. No further information is expected.
SEVERE PAIN IN SHOULDERS AND UPPER THIGHS, SENSITIVITY TO WATER TEMPERATURES, FATIGUED. No treatment at this time.
Pt recvd 3 doses of Engerix-B vax 1MAR91, 4APR91 & 3SEP91; On 6 or 7SEP91 p/3rd dose of vax pt exp urinary retention, numbess, dec sensation in lower extremity & weakness; also needed assistance to walk; dx transverse myelitis;
Information has been received from an health care worker in a physician's office concerning a 57 year old female patient who on 11AM of 26-SEP-2008 was vaccinated with PNEUMOVAX, lot number was reported as 659487/1960U. However, the vaccine was mistakenly administered intradermally. On 28-SEP-2008 ( a contradictory AE onset date given as 26-SEP-2008), the patient experienced hot flashes, anxiety, nausea, dry cough, pink-brown discoloration, burning at site. At the time of the report, the outcomes of these experienced were unknown. Additional information has been requested.
Received the 1st dose / on 26Mar2019 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of shingrix on 26th March 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. A pharmacist reported the patient was late for the 2nd dose, which lead to incomplete course of vaccination.  No symptoms was reported.  Reporter consented to follow up.   Follow up information received from pharmacist on 22nd June 2021: The batch number of 1st dose of Shingrix was updated (batch number LT7744, expiry date 1 July 2021, intramuscularly). The pharmacy technician tried to called patient on 23rd July 2019 for 2nd Shingrix vaccine to complete the series. The VAERS details were updated. The batch number of 1st dose was not found in sales data sheet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021044021:Possible same patient
Intense itching and redness at site of shot.  Covered with Cortisone 10.
Gums hurting and randomly starting bleeding without being touched. Gums very sensitive.   I also feel extremely tired since day of Injection. It is now two days later. My mouth feels strange like I?m clenching my jaw. Perhaps feeling more sensitive  to the physical effects of caffeine after only 1 small cup of coffee.
Case was vaccinated with covid vaccine on 5/6/21 & 5/27/21. Was admitted to Medical Center on 8/2/2021 with chest pain and shortness of breath. Tested positive for COVID 19. Case expired at Medical Center on 8/10/21.
Event: Itchy, swollen feeling in arm 6 hours after immunization. Noticed rash on from shoulder to elbow the following morning. Area is itchy and painful. Patient tried ibuprofen 400mg every four hours at home. Had some nausea, stomach pain, and subjective fever. Treatment: Zyrtec 10mg BID, Zantac 150mg BID x 5 days, Keflex 500mg QID x 5 days, Prednisone 40mg qday x 5 days. Outcome: At last follow up (10 days after initial encounter) patient still complained of itchy area on arm. Patient was instructed to continue Zyrtec and follow up in one week, but did not return for follow up.
muscle pull in the back; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: MUSCLE STRAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "muscle pull in the back". Therapeutic measures were taken as a result of muscle strain.  Additional information: Patient received his second dose of the Pfizer COVID vaccine on the 21Mar2021 and he saw his orthopedic doctor who gave him Toradol injection 1CC for a muscle pull in the back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have sharp pains in my bones in my upper chest area that comes and goes. A very bad headache, fever, weak, mild soreness on injection site. High blood sugar even after taking insulin.
Shakes and shivers; Hard to stand; Tired; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Feb2021 at 15:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to various foods, dust, pollens and dander. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was healthy and did not take any medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, on the day 1 of vaccination the patient was tired and  on 05Feb2021, day 2 the patient experienced shakes and shivers that lasted for one and half hours and the patient had hard to stand. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired and hard to stand were recovered on an unknown date in Feb2021 while the event shakes and shivers was recovered on 05Feb2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 at 16:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed; information about lot number cannot be obtained. No further information is expected.
Leg and foot  muscle cramps, several days, periodic, lasting 30 seconds each event, 6x Used stretching, massage, magnesium spray Severe headache ,  3-4 hours, 2 days , tylenol and rest Several days of fatigue
Redness around injection site, rash developed.  Client c/o itching without relief after taking Benadryl.  Saw MD 11-15-07, gave him a shot for itching and a Rx for Motrin & Benadryl.
Stomach pain, muscle aches, headache, dizziness, fever to 101.4
Hypertropic scarification at smallpox site. This pt is a 19 y/o primary vaccinee who recently returned. She was referred by occupational health for evaluation of a 6x6mm hyperpigmented, circular lesion at the site of the smallpox vaccination, which she received in March 2003. She has had the lesion since the time of healing of the vaccination site. She reports it is intermittently pruritic and is tender to palpation. After dermatology consultation, it was decided the lesion was hypertrophic scarification. It was injected with kenalog today and if it does not resolve will need to be injected again in 6 months. The dermatologist is confident this treatment should reduce the lesion and eliminate the hyperpigmentation; after treatment the site should be left with the appearance of the normal smallpox vaccination scar.
SEVERE CHILLS; SEVERE HEADACHE; SORE AT INJECTION SITE; TIRED; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031) dose was not reported, once a total administered on 07-MAR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced severe chills. On 07-MAR-2021, the subject experienced severe headache. On 07-MAR-2021, the subject experienced sore at injection site. On 07-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced fever. On 08-MAR-2021 09:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe chills, severe headache, sore at injection site, tired, and fever. This report was non-serious.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 07Apr2021 as dose 2, single (Lot number: EP7533), in right arm, on 04Nov2021 as dose 3 (booster) single (Lot number: FH8026), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "kidney stones" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN, start date: 10Jun2022, stop date: 31May2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2019.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Recurrence of runny nose, sneezing and coughing. Positive COVID test and had been free of symptoms but had not tested during that time.
Patient said he experienced fluid build up in lungs and coughing after receiving flu vaccination on 9/28/18. His coughing got worse and he saw his primary care physician on 10/2/18 who prescribed him Promethazine with Codeine. Patient said he did not have temperature or did not feel lethargic after the vaccination. Patient said he was very concerned about fluid build up in lungs which could lead to Pneumonia.
one of her coworkers had a very red face that benadryl helped; This is a spontaneous report from a contactable consumer. A patient (co-worker) of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reported one of her co-workers had a very red face that Benadryl helped on an unspecified date. Therapeutic measures were taken as a result of one of her co-workers had a very red face that Benadryl helped. The outcome of event was unknown.  Information about batch/ lot number has been requested.
Had the high dose (for over 65) flu vaccine. I am a very healthy 69 y/o - run Half marathons twice a year. After 8 hours, had bad chills, body aches, stomach ache, head ache, fever. Hives appeared 24 hours later. It is 48 hours now and I still do not feel 100% better.