chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # L037554, expiration date: 31-MAR-2019 and lot# M032650, expiration date: 31-MAR-2019 (dose and route of administration were not reported). The vaccine was exposed to temperature below 32 degrees Fahrenheit (0 degrees Celsius), the lowest temperature was minus 40 degrees Fahrenheit for 1 cycle. The vaccine was exposed to incorrect temperature for 6 days 23 hours and 30 minutes.  Digital data logger was involved and there was no previous temperature excursion. No adverse effects were reported. Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002783: US-009507513-1702USA002784: US-009507513-1702USA002782:
I experienced nausea, muscle pain, feeling very weak, chills, and shivering for 10 days. There was no treatment; eventually it went away.
Received Hep B shot 3-31-09 VLL.  On 4-02-09, mom notice it was reddened, hot and hives were appearing as well as swelling on the upper left thigh.  no respiratory symptoms.  PCP recommended cool packs and use of Benadryl.  4-06-09 swelling gone, reddness gone but still a few small welts around the injection site.
Error: Mixed Primary Series. Patient was accidentally given Pfizer 6mo-4yr COVID-19 vaccine as second dose in initial series after receiving Moderna 6mo-5yr as first dose in series 5 weeks prior.
Paleness, limp, passed out, incontinent nausea, trembling and shaking. Mother stated she took child to hospital. Continue to see MD. Pale for about one hour.
fever 102.8, cranky & inc sleepy; r/o sepsis, r/o meningitis, prob viral illness; happened w/in 4 wks p/Hep B vax given;
I had a slight fever; I just did not feel good; underneath it, it was kind of red; I was terribly tired for about 10 days; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunisation. The patient medical history included liver disease, primary biliary cirrhosis, 3 different times had stomach ulcers, breast cancer for at least 15 years and high blood pressure. The patient concomitant medications included ursodeoxycholic acid (URSODIOL) 300 mg 3 times a day for primary biliary cirrhosis, metoprolol (METOPROLOL) 50 mg once a day orally for high blood pressure, amlodipine (AMLODIPINE) 5mg once a day for high blood pressure and water pill for high blood pressure. The patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration as single dose for covid-19 immunisation and experienced tiredness for quite number of days. On an unspecified date in 2021, the day after the vaccination patient had slight fever, temperature. The patient did not feel good and area where she had vaccination, underneath it was kind of red but it was not warm or anything. The patient felt terribly tired for about 10 days. The patient did not receive treatment for events. The patient stated still not experiencing events and improved. The patient informed that she had no lab tests lately. The outcome of the events was recovered on 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Blood in stool x4 days; Began on 5/23/08. ROTATEQ administered on 5/19/08
Admitted 5/7/2021 with vasculitis on 5/7/2021 and bilateral intraparenchymal hemorrhages, requiring craniotomy for hematoma evacuation.
Hypertension; Generally did not feel well; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Hypertension) and MALAISE (Generally did not feel well) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced HYPERTENSION (Hypertension) and MALAISE (Generally did not feel well). On 26-Jan-2021, HYPERTENSION (Hypertension) and MALAISE (Generally did not feel well) was resolving.        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.  No treatment information was provided.
Nausea, muscle aches, headache onset at 2200 on 10-9-08. Emesis x 2 during the night. Mom using TYLENOL for comfort.
paresthesia of eye, possible TIA, onset 4 months p vaccine (dose 2/2) admin.  Pt requesting VAERS report completed.
The patient was flush and felt warm to the touch. She didn't register a fever that day but temperature was taken multiple times. She was very fussy (crying and didn't want to eat) around dinner time and I took her upstairs to get her ready for bed around 6:30pm. I gave her the bottle while I changed her diaper and put on pajamas. When I took the bottle away, she stared blankly and I picked her up. Her body went limp and her eyes rolled back. I immediately patted her back and yelled her name and she came back to consciousness within a couple of seconds. She cried for a little while and I gave her a pacifier to help soothe her. This all happened between 6:30 and 6:40pm.
PATIENT CONTACTS ME (THE PHARMACIST) AT PHARMACY ON 10/27/18 TO REPORT THAT THE FOLLOWING DAY AFTER HER FLU VACCINE, SHE DEVELOPED A INCREASE IN MUCUS PRODUCTION. SHE WENT ON TO EXPLAIN THAT SHE COULD NOT BREATHE WELL AND DECIDED TO VISIT THE EMERGENCY ROOM FOR MEDICAL EVALUATION. ONCE SHE WAS SEEN BY THE MEDICAL STAFF SHE WAS ADMITTED TO THE HOSPITAL. SUBSUQUENTLY, SHE DEVELOPED A PNEUMONIA AND A HEART ATTACK ALSO OCCURED WHILE IN THE HOSPITAL. THE PATIENT WAS AT HOME ON 10/27/18 WHEN SHE NOTIFIED ME OF THE INCIDENT. ALL INFORMATION IS FROM THE PATIENT'S TESTIMONY AND HAS NOT BE INDEPENDENTLY VERIFIED.
severe muscle pain in back and legs; Chills; Fatigue; Headache; severe pains in abdomen; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (COMARNITY; Lot/batch no: UNKNOWN) via an unspecified route of administration on 12Mar2021 at 09:00 AM (at 60-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included many food and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included fluticasone propionate (FLONASE) and essential amino supplements (MANUFACTURER UNKNOWN), for unknown indications from unknown dates and unknown if ongoing. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 09:00 PM, twelve hours after the injection, the patient had severe pains in abdomen with severe muscle pain in back and legs. The patient experienced some chills, headache and fatigue which were mostly over in 24 hours. The patient did not receive any treatment for these adverse events. At the time of this report, the patient was recovering from the events abdominal pain, muscle pain, chills, headache and fatigue.   No follow-up attempts are possible; information about lot number cannot be obtained.
About 8 hours after the injection I felt chills, night sweats, headache, lethargy, dizziness, muscle aches, pain in my entire right arm and loss of appetite. Lasted about 36 hours.
starting day after administration describes flu like symptoms, fatigue all joints painful not swollen/red. Fever to 102 degrees. Pain to left arm with a localized reaction of red/swollen/warm. No neurologic sx. Sx gradually resolved. Seen today first since injection with feeling near normal and much deminished scar/slight reddened/painful (L) arm at injection site. No joint pain and full use of muscles. No recent other vaccinations/illnesses. No other known cause for home sx. No relatedness with sx.
2 Moderna doses that were given 50 days apart; Slightly sorer left arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 Moderna doses that were given 50 days apart) and PAIN IN EXTREMITY (Slightly sorer left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Gastroesophageal reflux disease from 1995 to 1996, Asthma and Acid reflux (esophageal). Concurrent medical conditions included Iodine contrast media allergy (allergy reported: iodine contrast dye (anaphylactic reaction).) and Blood pressure high. Concomitant products included OMEPRAZOLE, HCTZ, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and AMLODIPINE BESILATE, OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milligram. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 Moderna doses that were given 50 days apart) and PAIN IN EXTREMITY (Slightly sorer left arm). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 Moderna doses that were given 50 days apart) had resolved. At the time of the report, PAIN IN EXTREMITY (Slightly sorer left arm) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-030063 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up on 21 Apr 2021 11:13 AM : added event 2 Moderna doses that were given 50 days apart. On 21-Apr-2021: same source document On 21-Apr-2021: same source document
Unable to blink left eye.  Unable to smile with left side of mouth.  Both appeared by the next morning.  I noticed it around 10:00am.  Left leg heavy cramp the night of around 5:30.  It went away when I stretched it and did not return.
3 month old received the Kinrix; Received the Kinrix as their 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The reporter reported that the 3 months 19 days old patient received the Kinrix vaccine. The reporter stated that the patient received Kinrix vaccine as their 2nd dose in the Dtap and IPV series. No reactions was reported. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that the patient received Kinrix as a 2nd dose in the Dtap and IPV series which led to which led to inappropriate schedule of vaccine administered.
felt crappy; feels like the flu; arm hurts; nauseous to stomach; chills; body was achy; headachy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt crappy), INFLUENZA LIKE ILLNESS (feels like the flu), PAIN (arm hurts), NAUSEA (nauseous to stomach) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (felt crappy), PAIN (arm hurts), NAUSEA (nauseous to stomach) and HEADACHE (headachy). 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like the flu), CHILLS (chills) and MYALGIA (body was achy). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN LOW) for Headache, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (felt crappy), INFLUENZA LIKE ILLNESS (feels like the flu), PAIN (arm hurts), NAUSEA (nauseous to stomach), CHILLS (chills), MYALGIA (body was achy) and HEADACHE (headachy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The reporter does not provide any causal relationship with  mRNA-1273 .
Felt warm, restless 10 to 11PM 13APR92; vomited @ 1145PM w/temp 105 R; APAP given 4PM & approx 730PM more APAP; Pt taken to hosp; 14MAY92 t100.2 R & diarrhea, cranky-stiff, can't walk;
Pt vaccinated with MMR slumped to floor, had brief 45 sec twitching(tonic clonic) seizure type activity of face & shoulders. Pale. Awoke promptly was alert & oriented - no sequellae. Probable vasovagal syncope with seizure
Patient was diaphoretic and lightheaded, denied SOB or CP. Patient rested and felt ok
Began complaining of chest pain, shortness of breath and neck pain. Became nauseous and shaking. To ER Chest X ray neg. Possibly musculoskeletal but? Vaccine reaction.
Patient reports "red baseball-size rash" at injection site, starting 4 days after vaccine. She is worried it will blister and turn into shingles rash.
Atypical febrile seizure 05/01/07-records received from facility for DOS 02/15/07 DX complex febrile seizure and fever viral illness.Tonic clonic seizure lasting greater than 30 minutes.PMH negative. In ED not responding to stimuli, noisy breathing. Temp 38.4. Admitted for observation.
pt recvd vax & a few days p/dose 2 exp induration @ inject site which lasted 2-3 days;
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered M-M-R II (Lot#, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition was not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding. Concomitant product use was not provided by the reporter. Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.    This case contains information about patient 2nd out of 8 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, 2 out of 8 patients
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from mother regarding an 18 month old son who experienced autism. The patient received the third dose on an unspecified date. Relevant medical history was not provided. Indication for Hib-Titer Vaccine was immunization. Product was administered on an unknown date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Acel-Imune Vaccine and Tetanus Toxoid Absorbed, Purogenated. Concomitant medications were not reported. The mother reported that her son was diagnosed with autism sometime in 2002 at 18 months of age. No additional information was available at the time of this report.
Presented to ED w/COVID symptoms; admitted for COVID-19 infection & hypoxia; tx w/ IV steroids, remdesivir, Vit C, melatonin, zinc; pt required 2L/NC and weaned to RA at discharge.
Acute Renal failure, Creatinine 4.3, BUN 33, hemo dialysis x3 weekly. Pt has been unable to find transportation to dialysis over the last several days. Pt complaints of SOB x3 days with cough. O2 saturation 99-100% on RA, Chest Xrays showing bilateral layering pleural effusions with no significant acute interstitial airspace disease.
Headache, NauseaVomiting, yes Narrative: Injection site pain, redness, swelling persisting into 4th day.
Had soreness of the injection site for two days after the administration. Then no issues. On the 8th day noticed Swelling and pain at the injection site, difficulty in raising the arm. Contacted my healthcare provider who advised to report to CDC, take anti-inflammatory and cold compress
Patient received first COVID vaccine on 11-29-22 which was Moderna at another facility. He came today to complete primary series and was given Pfizer as his second dose. Patient had no adverse event at time of vaccine today.
Starting experiencing hives and itchiness all over my body 11 days after booster shot moderna. Took prednisone for 10 days and steroid ointment cream. Did not help. Later took antibiotics Macrobid for a urinary tract infection. Hives still persisted after uti went away. also started experiencing increased heart palpitations and increased heart rate around Dec. 13. Started taking antihistamines hydroxyzine and Pepcid. Both have decreased the symptoms of itchiness and hives and dermatographia. However they do return if I stop taking medication. Now I am experiencing increased chest pain and tightness on January 18. I?ve been taking Zyrtec and pepcid consistently for two weeks since January 6. Dermatographia returns if I miss an antihistamine dosage. Heart palpitations still present. Chest pain is new.
Patient received first Pfizer Covid shot (along with Fluarix lot # 5cy4t exp 6/30/2023; patient has annual flu shots and has not had an adverse reaction to these before). After 15 minute waiting period, her tongue was dry and tingly. We requested she remain seated here for an additional 10-15 minutes to make sure she wasn't getting worse and had a staff member remain present with her. Few moments later, the staff informs me the patient says her throat feels tight. Proceeded to call EMS who arrived within 2 minutes of phone call. Patient was alert and oriented, did not fall or faint, and remained that way with EMS as they left for further evaluation.
The pt developed hives after 2nd dose of Hep B beginning approximately 21 hours post vax. The hives were confined to the upper torso, front and back. The pt's PMD has advised against further vaccinations with Hep B.
pt recvd vax JUL92 & 2 to 3 wks later pt exp coughing, congestion, low grade fever, lightheadedness & joint pains; no further details were provided;
uncharacteristic, random muscle cramping and pain in response to usual physical exertion and during periods of rest; whole body but mostly in lower legs uncharacteristic pain and muscle fatigue in lower legs after standing 10 minutes  time course: continuous since onset of symptoms There has been no change to my pre-vaccine medication, diet, or physical-activity routines that could account for these muscular symptoms.
Fever, swelling, arm pain, chills, dizziness, I fell due to body tremors, weakness, when I lay down I felt heavy things on my body, which I tried to remove for approximately two hours.
Outbreak of vessicular rash in L5/S1 distribution - burning pain with rash consistent with zoster.  Occured at non-vaccination site 1 day after zoster vaccine administered.
nerve pain; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Nov2021 (Lot number: 301458a) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: 301458a), administration date: 20Oct2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: NEURALGIA (non-serious) with onset 22Nov2021, outcome "not recovered", described as "nerve pain"; ASTHENIA (non-serious) with onset 22Nov2021, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of neuralgia, asthenia. No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US023211 is an initial spontaneous report received from a consumer on 04 NOV 2013. This case refers to a 12-year-old unknown gender patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported) at dose of 0.5 ml on an unknown date. No adverse event was reported following this administration error.