chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness on left side of my face; Sore shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Numbness on left side of my face) and ARTHRALGIA (Sore shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Numbness on left side of my face) and ARTHRALGIA (Sore shoulder). At the time of the report, VACCINATION SITE PAIN (Numbness on left side of my face) and ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
parent described-eye twitching & mouth pulled to the lt dx @ ER w/Bells palsy;
Gave FLUZONE intradermal at 10:00 - patient sat in waiting area as I went over side effects etc. At 10:05 pt got up to go get a Gatorade (as I was talking to his wife) when he got back to pharmacy area he fell face down he caught himself with his knee and hands and was laying face down with eyes wide open. I rolled him on his side he immediately came to consciousness. I propped his feet up; pt felt clammy, very pale, I took BP -100/60 - Fire and Rescue arrived and he began to get his color back - pt refused transport.
Client received the 1st dose of Moderna COVID vaccine and expiration date 5/22/21 at 1:30PM.  Client reports to EMT  and Nurse dizziness and tingling in her right finger.  Client received vaccine in left deltoid.  PHNs arrive to find patient sitting in chair alert and oriented x 4.  At 1:34pm vitals: blood pressure:172/94 , pulse:84 , and oxygen:98%. Client reports she has no medical history and takes no medications and has no known drug allergies. Client reports eating.  PHN noticed rash on back and PHN noticed rash to face and injection site on left deltoid. PHN  offers Intramuscular Benadryl , which client declined and asked for an oral benadryl.  PHNs offered client water, client accepted water. At 1:36PM  client took oral Benadryl.  Client reports no itchiness, no shortness of breath, client stated she was a little warm and had an itchy feeling in her throat that was starting to go away.  PHN  advised client to not drive due to Benadryl causing drowsiness. Client denies any drowsiness.  At 1:39pm vitals: blood pressure:170/90, pulse:78, and oxygen:98%.  Client reports no trouble breathing and dizziness has subsided.    At 1:44pm vitals: blood pressure: 150/70, pulse:79, and oxygen:97%. PHN notices rash on forehead and back rash started to clear up, client reports no itchiness and no more tingling in her finger and no longer feeling sensation of heat . Client reports "feeling like something is stuck in her throat" PHN  clarifies with client and client denies any shortness of breath.  Provide client with ER precautions and to follow up with her provider.  At 1:49pm vitals: blood pressure:160/100, pulse:82, and oxygen:98%. Client reports no chest pain, no headache, no dizziness, no trouble breathing, no more throat sensation that she had reported earlier.  PHN left to attend to another emergency in vaccination area. RN took over and took vitals at 1:55pm vitals: blood pressure:163/95 and pulse:77.  PHN  returns. At 2pm vitals: blood pressure:160/100, pulse:82, and oxygen:97%. Client denies any shortness of breath, pain, or tingling in fingers and rash is improving. PHN text supervisor with a text and a phone call, unable to contact.  At 2:05pm vitals are blood pressure:162/92, pulse:77, and oxygen:98%. Client denies any shortness of breath, discomfort or pain. Client remains alert and oriented. At 2:10pm vitals are blood pressure:170/98, pulse:74, and oxygen:98%. Client denies any chest pain, dizziness, headache or blurred vision, skin is warm and dry and rash still present but improving. Client remains alert and oriented. At 2:13pm PHN text Lead PHN  that blood pressure still elevated, rash has improved and no other symptoms. Client reports needing to use the restroom PHN  accompany client to restroom. PHN  meets client and PHN in the restroom and review ER precautions again. Client walked out with a steady gait at 2:17PM.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Additional Details: Patient said she felt strange and could not breathe.  We decided she needed an EpiPen and her daughter called EMS.  As I was about to administer it, she stopped me and said she was feeling better.  EMS came and checked her out and said all vitals were stable.  She left with her daughter and I just spoke with her again and she is still feeling well.
Pt recvd vax 6AUG92 & the next day had high fever; prior to immun pt had been hospitalized for acute asthma attack & had recvd steroids for 4 days;
01/11/2021  at 5pm started with diarrhea, chills, body aches.  01/12/2021 06:00pm facial swelling, lip swelling, hives.  Started Benadryl at home on 01/12/2020.  Seen by walk in PMD office 01/13/2021.  MD prescribe, 60mg prednisone and to continue Benadryl, 50mg as needed.
3/22/2021    was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  rapid heart rate. And clammy   Assessment : Time of assessment 1613 Alert and oriented.   Actions taken: Vs taken at 1613 BP- 121/69 P- 72, water offered         Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/22/2021  3:36 PM 0.3 mL 12/11/2020 Intramuscular
Pt had a breath holding spell and then started a seizure that lasted over 45 minutes. Given Valium and Ativan in ER. He has never done this before. Temperature 100.6. 60 day follow-up dated 9/26/00 states that the pt has changed to another doctor.
extremely sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (extremely sore arm) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (extremely sore arm). At the time of the report, PAIN IN EXTREMITY (extremely sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
he could not get warm; Bone cold; he slept a lot; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (he could not get warm), BONE DISORDER (Bone cold), SOMNOLENCE (he slept a lot) and FATIGUE (exhausted) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 044A21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Prostate cancer (Immunocompromised with prostrate cancer.). Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PREDNISONE ACETATE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), ATORVASTATIN, BUMETANIDE, CHOLECALCIFEROL, CLOPIDOGREL BISULFATE (PLAVIX), FAMOTIDINE (PEPCID [FAMOTIDINE]), FINASTERIDE (PROSCAR), METOPROLOL SUCCINATE (TOPROL XL), METFORMIN and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced FEELING COLD (he could not get warm) (seriousness criterion medically significant), BONE DISORDER (Bone cold) (seriousness criterion medically significant), SOMNOLENCE (he slept a lot) (seriousness criterion medically significant) and FATIGUE (exhausted) (seriousness criterion medically significant). At the time of the report, FEELING COLD (he could not get warm), BONE DISORDER (Bone cold), SOMNOLENCE (he slept a lot) and FATIGUE (exhausted) outcome was unknown.            No treatment informations were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected. Event terms, onset dates, outcomes and seriousness captured per Narrative, "bone cold" seems to be a typo error.   This case was linked to MOD-2021-303355 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected. Event terms, onset dates, outcomes and seriousness captured per Narrative, "bone cold" seems to be a typo error.
After one week of booster shot, I was lab tested positive for covid.; After one week of booster shot, I was lab tested positive for covid.; After one week of booster shot, I was lab tested positive for covid. Almost the same time, I was confirmed pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 19:00 (Lot number: 330258D) at the age of 31 years as dose 3 (booster), single, administered in arm left, administration date 18Apr2021 09:00 (Lot number: EW0162) as dose 2, single and administered in arm right, administration date 27Mar2021 11:00 (Lot number: ER8730) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "After one week of booster shot, I was lab tested positive for covid."; MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 27Dec2021, outcome "unknown", described as "After one week of booster shot, I was lab tested positive for covid. Almost the same time, I was confirmed pregnant". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab.  Clinical course: Patient stated, I received the booster vaccine at 27Dec2021, 2 days after I was conceived. After one week of booster shot, I was lab tested positive for covid. Almost the same time, I was confirmed pregnant. Until 29Jan21, I experienced the extreme pain in lower ab and bleeding. Later on, I was confirmed miscarriage by my provider. The patient had no known allergies. No other vaccine in four weeks. Patient took prenatal vitamin medications in two weeks. No covid prior vaccination. Post vaccination patient was COVID tested. No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a female who was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness and pain in her arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from pain in injection arm and is recovering from the numbness. Additional information has been requested.
1/3 of thigh (of injection site) swollen with induration and erythema. Treated with Benadryl and warm soaks.
Full Vaccinated case with positive Covid-19 test and Severe Covid-19 diseases. Patient in mechanical ventilation on ICU unit with respiratory failure.
pt recv vax & has been crying almost constantly since yesterday p/vax;crying is worst today;inj site described as red;has taken only 2 bottles of milk since yesterday;temp is 100.1;APAP given q 4hr;pt referred to clinic;
Rash on Bilateral arms; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash on Bilateral arms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Hypertension and Iodine allergy.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH (Rash on Bilateral arms). The patient was treated with LOSARTAN at an unspecified dose and frequency and SPIRONOLACTONE (SPIROLACTON) at an unspecified dose and frequency. At the time of the report, RASH (Rash on Bilateral arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Electrocardiogram: normal (normal) Normal.     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 reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: Follow up received on 9-Feb-2021 Regulatory Authority On 22-Apr-2021: Follow-up received on 22-Feb-2021
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 27th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nausea and shivering. On an unknown date, the outcome of the nausea and shivering were unknown. It was unknown if the reporter considered the nausea and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX vaccine last Tuesday before the date of reporting, and she was still feeling nausea and shivering at the time of reporting the patient took something for the nausea and bundled up, so it was a little better. The patient just want to ask if this was still within the timeline for adverse side effects.
Patient developed COVID-19 four days after the 1st Dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient developed COVID-19 four days after the 1st Dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (Patient developed COVID-19 four days after the 1st Dose). At the time of the report, COVID-19 (Patient developed COVID-19 four days after the 1st Dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Still tested positive on 04-Mar-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.  .   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR document was attached. No new information was reported.
Staff from office called patient 4/5/21 to schedule COVID19 vaccine #2.  Patient states that approximately 30-45 minutes after vaccination, she started to feel like her face was swelling.  The left side of her entire face did swell, including her neck and lymph nodes under her ear.  She denies difficulty breathing, swelling of throat.  She went to her PCP the following day, 3/13/21.  According to patient, she was given an injection while in office, but is unsure what it was.  She also was sent home with a course of antibiotics.  Patient states that the swelling improved throughout that week, but there is still enlarged, painful lymph nodes under her ear/neck area.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concomitant medication and drug reactions/allergies was not provided. On an unknown date, the reporter reported an alleged expired vial of GARDASIL 9 mixed in with a box of a different lot number (Product quality issue). On an unknown date, the patient inadvertently received the expired dose of GARDASIL 9 (lot# reported as N030380 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); lot # M030380 with expiration date 01-FEB-2019; strength and dose detail were not reported) intramuscularly for prophylaxis (Expired vaccine used).  No adverse effects were reported. The outcome of product quality issue was unknown. The causality of product quality issue was not provided.
Smallpox vaccine scab lasted longer than 8 weeks (8 weeks and 3 days). Vaccine date: 5/29/03, scab fell of on 07/27/03.
Pt vaccinated with Typhoid developed severe chilling feeling of having "no bones", weakness & severe HA, Temp 97. After 1 hr, T 103.5 (O) - given Tylenol. After 30 min T 102.6 (O). Sent home and observed by wife (corp person) given Tylenol.
Pt was given the 0.5ml dose of the 6m-11yr COVID vaccine instead of the 0.5ml of the 12+formulation.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot # N005619, expiration date 29-OCT-2018, orally, for prophylaxis (strength, dose and frequency  were not reported) and RECOMBIVAX HB lot # N020613, expiration date 05-MAY-2020, for prophylaxis (strength, dose, route and frequency were not reported). The temperature/Time frame was 34.8°F for 8 hours 23 minutes and 34.8°F for 8 hours 15 minutes. The previous temperature excursion was 47.6°F for 5 minutes. There was a data logger involved. No adverse effects reported. This is one of several cases from the same source. Sender's Comments: US-009507513-1710USA010654: US-009507513-1710USA010655: US-009507513-1710USA010656: US-009507513-1710USA010312.
This spontaneous report as received from a pharmacist refers to a currently 83 female patient. Patient with drug reactions/allergies: CIPRO (unspecified reaction). On 27-AUG-2012 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose 0.65 ml, lot number 0467AE, expiration date 04-APR-2013) subcutaneous. There was no concomitant medication reported. On an unknown date the patient experienced what might possibly be a case of shingles. The pharmacist did not observe the patient's skin of discuss the symptoms with patient in any details. The patient sought for medical attention and was prescribed famciclovir on 30-SEP-2014. The pharmacist reported that the patient returned to the pharmacy on 14-OCT-2014 (today) to report that her condition did not improve after her course of famciclovir. It was reported that the patient had not consulted with her prescriber physician about the fact that the famciclovir did not help her "rash" resolved at the time of this report. The outcome of the event was not recovered. This is one of two reports from the same source. Additional information has been requested.
Friday night (L) arm - swelled. Increased swelling on Saturday - Monday decreased swelling in arm - slight swelling (L) upper chest mom gave ibuprofen. On 3-17-14 given rx for BENADRYL.
This literature report (initial receipt 14-Aug-2012) concerns a 53 year old male patient. This literature report states amyotrophic lateral sclerosis (ALS) has been rarely reported after vaccination. On an unknown date, the patient received influenza vaccination. One month after vaccination, he developed brachial diplegia and respiratory muscles weakness requiring permanent non invasive ventilation. The event outcome was unknown. Reporter's comments: There is no cause-effect relationship between the occurrence of ALS and vaccination.
Approximately 5 minutes post vaccination, patient complained of throat tightness and difficulty speaking. EMS was activated. Pt was given 50mg Benadryl. Patient was then re-evaluated and symptoms improved. Patient reports allergies to nuts and fish but no other known allergies. Patient refused transport by EMS and released in greatly improved condition with precautions
Congestion & runny nose, resulting in sore throat and minor cough. Appeared to minor cold-like symptoms. Covid test taken at home and quarantined for suggested time frame according to  guidelines
Systemic: Reporting area of discoloration on chest, sensitive to touch-Mild.
Varicella vaccine given in (L) deltoid rather than subcutaneously in (L) upper arm.
This spontaneous case, initially received on 13-Sep-2018, reported by other healthcare professional, concerns a 51-year-old, adult, male patient. On an unspecified date, the patient (less than 65 years of age) was administered suspect vaccine FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed this case as non-serious.
Sxs started 8/9/07 in afternoon with redness, swelling, hardness and itchiness. Area very large in size, 10cm x 8cm. Sxs are at Varicella vaccine site.
Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml)) 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 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml)). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses  (0.5ml) for boosters instead of half doses (0.25ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Severe nausea, starting approximately 7 hours post vaccine, tapering off,  but still persisting slightly as of this report (3/24/21 a 12:40 pm) Low fever Chills Severe headache early morning 3/24/21