chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was ordered on 03-Jan-2022.  The beyond use date of the vaccine was reported as 02-Feb-2022.  The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed.   They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.   The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was provided.
the first night (last night), severe pain, the upper half of the arm; today is the second day, the temperature is going up slowly, continuously, now (at 3:30 pm) reached 102F.  Moderate headache too, especially after 100F temperature. The arm pain has decreased, continuously, only the fever and headache is a concern, now. This is the second dose of the same vaccine, the first dose has not produced any side effects, other than minor sore arm.
Muscle Cramps; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunization. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious) with onset 2021, outcome "recovering", described as "Muscle Cramps"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Arm pain". Therapeutic measures were not taken as a result of muscle spasms, pain in extremity.  Additional information: Pharmacy or Drug Store Facility used for COVID-19 vaccine administered. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Blood Pressure Meds within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. No known allergies:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient felt funny; Patient energy was kind of low after the vaccine"; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A (?)) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Diabetes and Drug allergy (opioids). Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension and Diabetes.    On 02-Jan-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 FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine"). At the time of the report, FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details was not reported by the reporter.   This case was linked to MOD-2022-664536 (Patient Link).
The pt vomited and appeared apneic about 1 hour post vax. The rescue squad delivered bag/valve mask ventilation. In the ER the pt had normal Physical exam except the pt experienced somnolence. The pt returned to normal mental status in ER was admitted to hospital overnight.
I was not feeling well and had a fever overnight along with a sore throat. I did have a family member who had tested positive for COVID-19, but I had tested negative that same day that I started I not feeling well. The next day I was worse with a sore throat, a cough, runny nose and the fever was still happening. I reached out to my health care provider when my fever was not going away and at that point, I had tested positive. I was offered Paxlovid but declined but was given a medication for the runny nose. I did have my flu shot the same day that I had my COVID-19 vaccine, but I do not have the information for that shot. I am testing negative, but I am still coughing and have a lot of phlegm and lung congestion.
Information has been received from a physician concerning a 60 year old female banker with a history of type II diabetes mellitus and no acute illness at time of vaccination,who on 21-Jan-2009 at 12:00 was vaccinated with a first dose of ZOSTAVAX (Merck) (lot# 663572/1709X), subcutaneously into the left arm. On 25-Feb-2009 the patient experienced rash most consistent with pityriasis rosea. No further information is available.
Mom reports hives all over 5-6 hours after vaccines. She used BENADRYL and patient was improved the next morning. No other symptoms besides rash.
Information has been received from a man in a drug store concerning a female nurse who on approximately 12/21/01 was drawing up pneumococcal vaccine 23 polyvalent and poked herself. Subsequently, her finger swelled. It was unknown if the patient sought medical attention. Follow up information received from medical records indicated that on 12/18/01 the registered nurse inadvertently poked herself in the left middle finger with a clean, sterile needle. That night, the finger began to throb and became red with some inflammation. On 12/19/01, the patient presented to the physician and it was noted that she appeared healthy and was in no acute distress. The physician reported that on 12/19/01 it was even worse. On the flexor aspect of her left hand, particularly in the region just distal to the left middle finger metacarpophalangeal joinct (MCP), was swelling, redness and some streaking back up over the palmar aspect of the left hand. There was a very tiny puncture wound, which represented the needle. On 12/19/01 the patient was assessed as having cellulitis secondary to the needle stick. It was noted that the nurse was 100% sure that this was a clean, unused needle. On gram of ceftriaxone sodium (ROCEPHIN) IM was given in the office. She was prescribed cephalexin (KEFLEX) 500 mg PO QID x 10 days. She was sent home and advised to elevate her arm. On 12/20/01 the patient returned for a follow up visit and her finger was more swollen, though less red. She found it very difficult to flex the finger. The physician observed that the left middle finger was swollen from the MCP distally. There was good coloration at the very proximal portion of the finger, and there was less redness than yesterday, but overall more swelling. There was no streaking up the hand towards the arm. On 12/20/01 the patient was assessed as having cellulitis, less likely would be an allergic reaction, but I cannot exclude it. The patient continued with the cephalexin (KEFLEX) as prescribed. Another gram of ceftriaxone sodium (ROCEPHIN) was administered, and it was recommended that she try fexofenadine (ALLEGRA) 60 mg BID to see if the antihistamine effect would reduce some of the swelling. The physician noted that they were gathering all the pneumococcal vaccine 23 polyvalent vials that they had, would not be using them, and were concerned about the possibility of contamination. On 12/21/01 the patient returned again for a follow up visit. It was noted that her finger was still swollen, but was improving. The redness and inflammation was less than it was the day before. There was no streaking up the palm or the forearm. The physician's final assessment was an acute inflammatory reaction following a needle stick injury. It was reported that the needle was clean as noted that the reaction was either allergic or infectious. The patient continued with the cephalexin (KEFLEX) and antihistamines as needed. She was to keep her finger elevated. Additional information has been requested. A 15-day follow up report received 8/5/03 adds no new info.
Reported a side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Reported a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided. No concomitant medication details provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (Reported a side effect). At the time of the report, ADVERSE EVENT (Reported a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided. No relevant concomitant medications reported.
Still contracted HPV18 even after complete vaccine series. Currently now has CIN3 atypical cervical cells.
Passed out; Blood pressure was low for him: 112/54; temp was also low: 96.6; thirsty; feel funny; This is a spontaneous report from a contactable consumer reported for self. This 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 14:45 PM on Arm left at single dose (Lot # ER8732) for covid-19 immunisation. Medical history included Sleep apnea, breathing issues, IBS, Hypertension; Anxiety/Depressive disorder. No known allergies. No covid prior vaccination. Concomitant medications included other medications in two weeks. No other vaccine in four weeks. On 26Mar2021 08:00 AM, he went to the bathroom around 8 a.m. this morning and started to feel funny. He stood up and passed out onto the floor. Family members heard him and came to help. Blood pressure was low for him: 112/54. Temp was also low: 96.6. He was very thirsty. No treatments received. No covid tested post vaccination. Outcome of the events was recovering.
Seizure x 2. 1st with palpable fever, 100 degree R in ER, 7 hours after vaccines given. Second seizure 32+ hours after vaccines, with 101 degrees R. Septic work up with L.P. negative. Some diarrhea.
5/22/06: Rash, fever, joint pain, lymph nodes enlarged left neck
VR presented to the vaccination site for a second dose of pfizer.  VRs first dose was pfizer.  The Vaccinator confirmed with the VR and with the administrator that the VR would be receiving Pfizer as a second dose, however the Vaccinator gave the Moderna vaccine.  I discussed this with the VR at great length.  The VR left without any additional questions.
Sore upper arm/muscle, reduced range of motion. Symptoms (re)appeared on day 9-10 after vaccination and have continued through today (day 17), and appear to be getting slightly worse. Pain is mild to moderate but certain movements make it much worse.   (This is beyond initial symptoms - fever, headache, muscle aches and sore injection site, which all resolved w/in approximately 36 hours of vaccine administration.)
Allergic reaction to vaccine. Erythema, tenderness, and swelling, itchiness at injection site. TX symptomatically with BENADRYL, ibuprofen, and ice packs.
Shot on DEC 21-2009 DEC 22 Dizzy, nausea, muscle ache, weakness, no appetite, hospital DEC 24 and 25th many Dr visits hoarseness, cough, still ill Feb 26-2010. Rapid heart.
Initial report received on 22/Mar/2006 from a health care provider. A 75-year-old female patient with no illnesses at the time of the vaccination had received an intramuscular injection of DECAVAC, manufacturer sanofi pasteur, Inc. , lot number U1636CA, in the right deltoid on 15/Mar/2006. A few hours later, she developed 4cm induration, redness and warmth at the injection site spreading down to the elbow. It is unknown when her last tetanus booster was received. At the time of this report, the patient had not recovered from these events. Follow-up information received on 15/May/2006 from reporter. Per reporter, the patient's symptoms began three hours post vaccination, however was not reported until one week later. The patient recovered. No further information expected.
c/o Tender "lymph nodes" L lateral chest wall next to L breast / noticed App. 1 week after smallpox vaccination administered on 13 Dec 09.
family member had recently passed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (family member had recently passed) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   No treatment information was provided.  Company comment: This spontaneous case reported by a patient family member, concerns an adult patient of unknown gender with no reported medical history, who met with a fatal outcome (PT: Death). Death occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. Other details are not available for medical review. Exact cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.    Reporter did not allow further contact; Reported Cause(s) of Death: family member had recently passed
EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021   to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme fatigue was not reported. This report was non-serious.    .
Swollen tongue, hands, wrist, armpits, feet. Itchy throat/caugh, itchy wrists, palms, ears, buttocks, feet, armpits. Developed hives on wrists, armpits, buttocks, left arm around injection site.  Received 1 shot left arm 09:30 A.M. first sign of reaction was itchiness left palm and injection site 1 minute after injection. Within 5 minutes itchiness spread to palms, wrists, ears, throat, feet, armpits, buttocks. After 5 minutes noticed swelling in hands, feet and tongue followed with hived around armpits, both wrists, buttocks, left arm.
Pt developed joint pain, muscle pain & weakness x 1wk; severe weakness in legs followed by facial & trunk rash, mouth ulcerations, dryness, gingival swelling, tympanic memb white, severe conjunctival inflam; Detailed see WORM;
Fatigue, headache, body aches and chills beginning around 8pm day of injection, worsening through the night. Body aches and fatigue still present next day, chills present in the morning but lessened as day progressed. No headache the next day. No fever at any point.
patient reports pain and redness from shoulder to elbow starting approximately 12 hours after vaccination. Pt had fever of 101.5 for 24 hours and well as dizziness and nausea. All symptoms resolved within 72 hours of vaccine adminstration.
Swollen lymph node that started spreading inside the arm and on the down of the arm; Bad rash on left arm that is traveling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node that started spreading inside the arm and on the down of the arm) and VACCINATION SITE RASH (Bad rash on left arm that is traveling) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE RASH (Bad rash on left arm that is traveling). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node that started spreading inside the arm and on the down of the arm). At the time of the report, LYMPHADENOPATHY (Swollen lymph node that started spreading inside the arm and on the down of the arm) and VACCINATION SITE RASH (Bad rash on left arm that is traveling) outcome was unknown.            Treatment using antibiotics, antihistamines and steroids was reported It was reported that patient is feeling fine now and there are no other issues The reporter does not want another follow-up call   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event details updated, treatment details updated
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-024017 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024017:crosslink
Patient reported swelling around the left arm near the injection site and was first noticed the morning after the injection.  Was slightly painful to the touch and warm.  Patient advised to treat with ibuprofen and cold compress and if worsened to seek medical attention.
Per Client received a Pfizer COVID 19 on 4/5/2021 in right arm around 12:00 pm at the site.  Per Client, around 1210 pm started having symptoms, head heaviness, almost feeling like she was "high".  Client reports that on next day of 4/7/2021, intermittent wheezing, slight SOB when wearing a mask. Per Client symptoms lasted for three days and without symptoms today.  Client reported no medications taken for symptoms and no follow up with MD. PHN suggested that Client follow up with PCP and if needed with any worsening symptoms or medical emergency to call 911. Client verbalized understanding information provided by PHN.
Pt complained of worsening cough, weakness and shortness of breath over the last 10 days. Pt has uncontrolled diabetes mellitus and COPD with a history of renal cell cancer. Pt was found to be COVID positive.
Pt recv vax on 3/17/98,3/31/98, 4/18/98, 9/30/98; in 11/98 pt exp rash on belly button w/ soreness& brown color
Relapsing Polychondritis; Severe external ear redness and swelling of it, plus the canal; Severe external ear redness and swelling of it, plus the canal; Severe external ear redness and swelling of it, plus the canal; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Autoimmune patient" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: POLYCHONDRITIS (medically significant) with onset 2021, outcome "unknown", described as "Relapsing Polychondritis"; ERYTHEMA (medically significant), EAR SWELLING (medically significant), EAR CANAL ERYTHEMA (medically significant) all with onset 2021, outcome "unknown" and all described as "Severe external ear redness and swelling of it, plus the canal". The events "relapsing polychondritis" and "severe external ear redness and swelling of it, plus the canal" were evaluated at the physician office visit. Therapeutic measures were taken as a result of polychondritis, erythema, ear swelling, ear canal erythema. Clinical course details: It was reported that patient is autoimmune, and fully vaccinated, plus booster, as of early Nov2021. Within two weeks of receiving the booster, patient developed a severe external ear redness and swelling of it, plus the canal. After three rounds of antibiotics, steroids, ENT, Internal Medicine doctors, and Rheumatologist, it has been determined that patient very likely have Relapsing Polychondritis, a debilitating disease. Patient reported it appears probable that this a result of the booster. More cases were discovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.