chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 or 3 minutes after the vaccine I started feeling really hot. When the nurse came to ask me if I was ok I told her that I needed some water. When I was drinking the water I was having problems swallowing. Then I started having problems breathing. I then broke down on a rash my skin was so red it looked like I was sun burned. My skin also peeled. Then I was taken into the emergency room by ambulance. They put an IV on me when I got to the hospital. They put a steroid & pepcid famotidine. They told me if I was not better by the next day to go back. My voice also goes occasionally & I still don't have energy.
joint pain; 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 ARTHRALGIA (joint pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided. No concomitant medication provided.   Reporter did not allow further contact
04/13/2021 the patient's arm became swollen, red, and hot to the touch. She developed a UTI (confirmed through an at home UTI test) and has been treating at home for the past two days. On the night of 04/13/2021 the patient started having diarrhea that continued until 3:30pm 04/14/2021 after taking Imodium and Pepto Bismol. No fever. The patient did not seek medical help because she did not believe her symptoms were that severe at the time.
When patient presented to his neurology appointment, patient states approximately 2 weeks after 2nd moderna injection c/o numbness in all fingers.
8yo who has not completed the DTaP series / has sustained dog bite; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 8-year-old patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP Vaccine (on an unknown date, received previous unspecified number of doses). Concurrent medical conditions included dog bite (had sustained dog bite).   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported are as follows: The age at vaccination not applicable for this report. Nurse Practitioner reported that, the patient did not complete the DTaP series and had sustained dog bite. Adverse event was captured via chat, unsure if this was a GSK vaccine or not as brand name was not provided by Health care professional and chat was disconnected by Health care professional  prior to providing any additional details about scheduling of DTaP or demographic details. It was not specified, how many doses the patient had received but stated that, the series was not completed. No additional data provided and only contact information provided was email address and zip code. The reporter did not consented to follow up.
Arm felt extra heavy for 10 minutes. Hours later it became sore for a day.
Hearing loss in left ear (same side as administration); has not worsened or gotten better since onset.
I was 21 weeks pregnant when I received the Flu vaccine and in less than 2 weeks later my baby was dead. I believe the flu shot was poison to my baby.
Immediately after vaccination, patient developed a hard nodule about 1" in diameter. She said it did not hurt and she had previous vaccinations without issue.
10:10am Gave expired vaccine; pt. notified and revaccinated at 1:00pm 4/30/12.
A doctor got COVID after receiving a COVID-19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (A doctor got COVID after receiving a COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 COVID-19 (A doctor got COVID after receiving a COVID-19 Vaccine). At the time of the report, COVID-19 (A doctor got COVID after receiving a COVID-19 Vaccine) 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 medications were reported.  Reported states that a doctor got Covid after receiving a Covid-19 Vaccine of unknown manufacturer.  No treatment medications were reported.  On 13-Aug-2022, the case MOD-2022-627368 became invalid as the suspect drug manufacturer was not known.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Upon internal review on 16-Aug-2022, significant correction was performed. Validity of the case has been upgraded from invalid to valid hence report type and classification was updated. Suspect product coding was updated from Moderna Covid-19 vaccine to Spikevax. Corresponding field and narrative updated accordingly.
SEVERE SIDE EFFECTS AT NIGHT; SHAKING/MOVING; COULD NOT GET OUT OF BED; CHILLS; HIGH FEVER; FATIGUED/TIRED; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 60 year old female. 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects at night, shaking/moving, could not get out of bed, chills, high fever, fatigued/tired, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigued/tired, and weakness, and the outcome of severe side effects at night, chills, shaking/moving, could not get out of bed and high fever was not reported. This report was non-serious.
Patient received H1N1 mist (2nd dose) at 08:30am on 12/8/09. At approximately 0300 on 12/9/2009 patient began experiencing eye and lip swelling. Benadryl (oral) was administered and swelling resolved.
Pediatric dose was given to adult mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Poor quality product administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 104 of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master Case
Fainted and hit head, ,fever, threw up, bad headache, nausea, body aches so bad that it hurt her to touch her anywhere, chest heavy, mouth felt like something in it Lasted for about 36 hours and then weak for another 12 hours Took Tylenol and Motrin after calling Doctor
This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoporosis, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, 01 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient experienced breakthrough infection. The patient experienced symptoms included mild sore throat and felt tired and then first took coronavirus disease-19 (COVID-19) rapid point of care (POC) test that came back positive. Then on 01-NOV-2021, the patient again underwent laboratory test which included COVID-19 polymerase chain reaction (PCR) test that came out positive as well which resulted in confirmed clinical vaccination failure. She also visited to physician office. Reportedly, she received the monoclonal antibody treatment for COVID-19. Her symptoms were resolved more than a month ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208046.; Sender's Comments: V0:20211247875-covid-19 vaccine ad26.cov2.s- breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211247875-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Asthma type wheezing(patient is not asthmatic), fever, chills, body aches
Pt developed full body rash. Sx of itching and pain. Non vesicular papules. Pt seen for doctor's appt on 9/2/14 at 3:30 pm. Rash developed at admin site, spread to neck, down LA, then to the rest of body.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006668 and 20211006371.
Tonic-clonic seizure.  Jerking extremities, duskiness of lips, no memory of events, rigidity, tongue biting, sore muscles in extremities post seizure lasting a week or more.
Redness at injection site; Pain at injection site; Blistering; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema, injection site pain and blister. On an unknown date, the outcome of the injection site erythema, injection site pain and blister were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain and blister to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist reported that the patient received FluLaval Quadrivalent and had redness, blister and pain at the injection site. The reporter consented to follow up. The Registered Pharmacist has no further details but was agreeable to recontract. This case linked with US2019AMR165267and US2019AMR165268, reported by same reporter.
aches; low grade fever; chills; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (aches), PYREXIA (low grade fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    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 MYALGIA (aches), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MYALGIA (aches), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were provided.   This case was linked to MOD21-091918, US-MODERNATX, INC.-MOD-2021-156255 (E2B Linked Report). This case was linked to MOD-2021-148248 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: FW Added on 20-MAY-2021 .Possible-NNI; Sender's Comments:  MOD21-091918: US-MODERNATX, INC.-MOD-2021-156255:
Information has been received from a registered nurse referring to her son, a 21 year old male patient. In July 2015, about 1 month ago the patient was vaccinated with one dose of ZOSTAVAX (route, strength, lot# and dose were unknown) by an unspecified physician (inappropriate schedule of drug administration). No adverse reactions had been reported. Additional information has been requested.
Patient received an expired dose of Pfizer pediatric vaccine. No treatment given at this time. No symptoms reported at this time.
brain fog; Extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog) and FATIGUE (Extreme exhaustion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Sleep problem.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (brain fog) and FATIGUE (Extreme exhaustion). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency and ZINC for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (brain fog) and FATIGUE (Extreme exhaustion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were supplements and vitamins. Treatment also included lots of fluids and rest.   This case was linked to MOD-2021-395717, MOD-2021-395927 (Patient Link).
HEADACHE; This spontaneous report received from a patient concerned a 53 year old male. 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: 042A21A, and  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache. This report was non-serious.
Ex 29-week premature infant presented for routinue post NICU follow-up on 6/5/08 for 2mo.  Relatively nml Pexam (hx of RDS,Apnea, R/o spesis, anemia, hyperbilirubinemia, cholestatic jaundice, murmur, bilat inguinal hernia)  Of note only jaundice and murmur were present at time of discharge.  Patient recieved 4 vaccines on 6/5/08.  Patient presented with URI symptoms on 6/9/08 diagnoses with URI and sent home.  The baby reportedly had a cardiac arrest later that evening and did not survive. ****please note submission of similar patient of similar event with ALTE diagnosis and hospitalization (survived).  6/27/08 Link w/317530 per direction of FDA.  9/24/08 ER record received for DOD 6/10/08.  DX:  Sudden Death.  CPR unsuccessful.  Infant last seen alive at 1800. EMS on scene at 22:35. Pt found cold, stiff and puple in color.  CPR attempted but unsuccessful. Pt in rigor upon arrival in ED and prounounced. PMH: 28 wk premie. In NICU from DOB 3/29/08 until 4/29/08 with DX: Respiratory Distress syndrome.  Apnea of Prematurity.  R/O Sepsis x3.  R/O NEC. Jaundice.  Nutritional support. R/O IVH and PVL.  Temperature Support. Infant on CPAP and NC O2. Had apnea, bradycardia and O2 desats.  3 episodes of sepsis w/u. Had physiologic jaundice requiring phototherapy. On parenteral feeds with intermittant enteral feeds. D/C on O2 and monitoring./pc 9/29/08 ME's report received.  Probable COD Acute Bronchopneumonia.  DX:  Acute bronchopnemonia, moderate.  Cholestasis. Microscopic exam of the lungs reveals moderate acute bronchopneumonia present w/in the major and minor bronchi and alveolar spaces.  Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present.  Slight chronic inflammation.  Severe autolysis.  10/30/08 PCP records received which include d/c summary for 2+month NICU stay with D/C 6/4/08. Seen in f/u 6/5/08-cholestatic jaundice, anemia, ROP and scrotal masses (hydroceles) noted. Otherwise normal premie exam. Vax given. Seen again 6/9/08 for cough and congestion with Impression URI. RR 60. P ox 95%. Wet cough, wheeze and rhonchi noted (clear A/P/L). Nasal saline and suction as sympromatic care. To f/u in 1-2 days or to ER PRN.
Small  toes in my left foot remain swollen and numb. The small toes no longer move in the same way as on my right foot. The Metatarsal  bones in both feet give me pain during the day and the night.  I have tried Epsom Salt soaks and Ice Packs.
Patient received the MODERNA BIVALENT but should have received MODERNA MONOVALENT.  The patient had never received and COVID vaccinations.
On 7:30pm on 12/6/09 experienced intense itching, swelling, erythema and red papules at injection site. R shoulder area, R inner thigh and knee, R calf and shin. No systemic symptoms. At 8pm took 1 BENADRYL tablet - no relief at 8:30pm took 2nd BENADRYL tablet - relief also applied CALADRYL lotion to affected areas. On 12/7/09 non-itchy red spots with black and blue spots where scratched.
swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen arm). At the time of the report, VACCINATION SITE SWELLING (swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Burning, tingling sensation on injection site (left deltoid) went to neck back, arms and fingers. Nausea, took TYLENOL and felt better.
Patient received vaccine Saturday (Dec 4th) and Sunday (Dec5th). He awoke with a severe headache, stiff neck radiating to small of back and swollen hot arm at injection site. He went to the ER and diagnosis of myalgia / myositis. He was treated with Percocat and Phenegan. Referred to his PLM for follow up i 3-7 days. At follow up the doctor prescribed medical dose pack x 1 week for continued symptoms.
This spontaneous report as received from a physician refers to a 19 year old female patient with no pertinent medical history or drug reactions/allergies. In approximately July 2014 ("last month") the patient was vaccinated with first dose of GARDASIL lot #, expiration date not reported, 0.5 ml, intramuscular. There was no concomitant medication. The patient's mother called the office and was very upset because the patient had not had her period for one month after the first dose of GARDASIL and had not had her period at the time  of the call. There was no treatment given for the event. No lab diagnostics studies performed. The outcome of the event was reported as not recovered. This is one of the report from the same source. Additional information has been requested.
Woke up with sore left arm and headache. As day progressed headache continued and had several episodes of feeling hot, sweaty, and nauseous. At approximately 8 pm I had another episode of feeling unwell. I sat down on couch and had a seizure. Arms went straight out from body, legs got tense, loud noise  from mouth, then was slumped over on couch. Husband got me to the pickup and drove me to the emergency room.