chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on 11/5/98; 15-20 min later pt exp sleepiness, crying, limb tremors, cyanosis of hands, cheeks & lips; dx=possible seizure
My daughter and I went together for all thress of our shots/she had soreness a few days but then it went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 3 (booster), single (Lot number: FL3198) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2, Anatomical site of injection: Upper arm, Route of administration: Intramuscular, Batch/lot number: FC3180), administration date: 09Aug2021, for Covid-19 Immunization; BNT162b2 (Dose: 1, Anatomical site of injection: Upper arm, Route of administration: Intramuscular, Batch/lot number: FA6780), administration date: 19Jul2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Feb2022, outcome "recovered" (2022), described as "My daughter and I went together for all thress of our shots/she had soreness a few days but then it went away".  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). No prior vaccinations and no specific relevant tests. No treatment. I received the COVID booster on 09Feb2022. There was soreness in my arm at the injection site following the injection, which was normal. I noticed the next week that I still had Soreness at the injection site. My daughter and I went together for all three of our shots. I asked her if she noticed any thing and she told me she had soreness a few days but then it went away. It is going on three months since had the booster and there is still soreness in my arm where I was injected. More noticeable soreness /slight pain when actively using my arms manual labour, working on some-thing over head. Sometimes just have an achiness in my arm for no reason. Asked pharmacist if anything had been put out regarding this negative reply. Emailed Pfizer about it was instructed to call. Have not seen any medical professionals about issue.
I was fully vaccinated and boosted and got Covid on 12/4/2022. Since I have two conditions that put me at higher risk, my Dr. prescribed paxlovid. I took it for the five day course and felt pretty good. I used a covid test and was negative after five days of paxlovid and five days masking. Three days later, I had symptoms of a bad head cold. I tested positive for covid. I called the Dr. and they recommended five day quarantine again and five days masking. I feel a lot worse with this second round. Tired, sensitive skin, head stuffy and nose running constantly.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------------- ACUTE ST ELEVATION MI, LATERAL WALL 10/14/2022 ST ELEVATION MI INVOLV LT CIRCUMFLEX COR ARTERY
Left upper arm slightly swelling, erythematous, tired, left arm tingling 6" x 4" area, itchy, warm to touch tx: ZYRTEC and OTC steroid cream.
Patient was receiving dialysis and had low grade fevers on the morning on 1/15/2021. Patient was sent to the hospital's emergency room and was found to have a temperature of 103. The patient also had mental status changes. It is unsure what caused the mental status changes and fevers.
Pt 20 y/o female found ambulatory at vaccination site. c/c weak/dizzy, borderline hypotensive. Pt received her first doser of Moderna COVID-019 vaccine at approximately 1040hrs. Pt was monitored for 15 minutes in a designated area. Upon standing up pt became lightheaded and dizzy. Pt sat down and notified staff of feeling weak and dizzy. Responder was notified and responded to pt. Pt denied any chest pain or shortness of breath. Minor nausea but no vomiting. Pt had equal grips and pushes, no headache, blurred vision or tinnitus. Abdomen was soft and non tender on palpation. No hives, rash or redness noted. Pt was given 500cc of NS via IV, 20g in L AC. Pt was positive orthostatic and was laid down supine on a blanket. Last LPM 30 days ago. Gravida 0, Para 0. Pt states she has had syncopal episodes during menstrual period. Pt denied any food intake this morning. Pt was transported byto Hospital. Vital signs improved with administration of NS.   Vital Signs: BP 106/52, HR96, SPO2 99%. (1052hrs) BP 118/76, HR 68, SPO2 99% Hx: Syncope during menstruation, Anxiety, borderline hypotensive.  Allergies: NKDA Medicine: None
pt recv vax; high pitched cry;became limp, pale & eyes rolled back in head;was gasping for air; to er;
About 5-7 seconds after the vaccine was administered,  I started to feel a tingling sensation in my lower legs, that moved up my legs, and was accompanied by a rapid heart beat. This subsided after 1 or 2 minutes.  At the time, I assumed it was anxiety, and because I was  sitting in my car, I turned my air conditioning on my face to cool down.  Afterward, I told a man what happened, and he asked me how I was feeling at that point, and that he wanted me to stay there for an additional 5 minutes for observation. After researching,  I feel it was an allergic reaction, not anxiety.
Pt was 17.83 yrs of age at time of vaccine administration; not 18 years. Pt was choosen to prevent a wasted dose; pt also employee of pharmacy as a delivery driver. Pt's father also employee of pharmacy who had a heart transplant last year. Pt had nausea about 12 hours after shot; only lasted about 12 hours. By 24 hours after shot no remaining issues other than pain at injection site.
reaction; didn't feel well; The solution that was injected was red; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (reaction), MALAISE (didn't feel well) and PRODUCT QUALITY ISSUE (The solution that was injected was red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029K20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction), MALAISE (didn't feel well) and PRODUCT QUALITY ISSUE (The solution that was injected was red). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown and MALAISE (didn't feel well) and PRODUCT QUALITY ISSUE (The solution that was injected was red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up received on 13-SEP-2021 contains no new information .Reporter had stated that" This was an error on patient's part so please cancel or close case"
No adverse event; Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, 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. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date).    The vaccine was delivered to the hospital on 20-Sep-2022.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 9th of 9th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-725025 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725025:master case
Flu like symptoms, sneezing, runny nose, stomach pain and achy all over. Low grade fever one day.
Information has been received from a 53 year old male physician with hyperlipidaemia, hypothyroidism, allergic rhinitis, and drug allergies to penicillin, cephalosporins, and NSAIDs who in 2001 was vaccinated with a first dose of Pneumovax 23 vaccine. On 22-JAN-2007, the physician was vaccination with a second dose of Pneumovax 23 (lot 655501/1035F). There was no concomitant medication. On 23-JAN-2007 the physician developed lymphoedema in the injected arm, fatigue, pain and malaise. The physician sought unspecified medical attention. At the time of this report, the physician was recovering. Additional information has been requested.
11:40 Vasovagal response-fainted. VS: 107/72, HR 65 , RR 16, O2 100%.   Laid down. juice, water and ice packs offered.   Patient left observation area with her mom at 11:50.
Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 minutes after vaccination. Received Benadryl, then treated with treated with epinephrine or EpiPen. Transported by EMS to hospital where she received IV famotidine and methylprednisolone sodium succinate.
Lymph node swelling, axillary that was painful; fatigue, chills at night, low energy; Treated with course of Bactrim DS BID for 10 days; sxs recurred and sonogram was performed. It confirmed the swelling was lymph nodes but did not appear pathologic. May have mammogram and sonogram pending but now suspicious this may be reaction to vaccine. Labs for mono and her CBC were normal.
Thrombotic microangiopathy presenting as status epilepticus. Presumed atypical HUS with neg genetic tests. Treated plasma exchange, oral steroids and complement suppression.
BUD DATE 4/7/2022  Booster given 04/14/2022 Pfizer could not verify stability beyond 4//9/2022 and recommended revaccinating so another booster given  on 05/11/2022
lost sense of smell; cold like symptoms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cold like symptoms on 24Dec2020. Then on the 26th (26Dec2020), patient lost sense of smell. Outcome of events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Redness, swelling, warm-to-touch, nodule/hardness (under the skin) localized to around the injection site starting 1-2 days after the vaccine and still present 14 days post-vaccination TREATMENT: ibuprofen OTC to help with swelling
A physician reported that a 5 year old child received Acel-Imune and Orimune and subsequently, developed an injection site reaction characterized by a large, red and raised area. The pt recovered. The reporter indicated that 2, 5 year old pts, from this facility experienced this event following receipt of Acel-Imune; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Vaccine received at 0914, reaction occurred at 1008. Difficulty breathing, swelling to upper and lower lips, throat tightening, audible wheezing, rash to neck and chest. Two doses of Epinephrine and Benadryl given, oxygen administered, EMS called and taking to hospital via EMS at 1027.
Patient was underage at the time of vaccination. Attempted to make contact with patient using number on file-no contact made.
Since then her right arm has been bothering her; Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection) and PAIN IN EXTREMITY (Since then her right arm has been bothering her) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection). On an unknown date, the patient experienced PAIN IN EXTREMITY (Since then her right arm has been bothering her). At the time of the report, VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection) and PAIN IN EXTREMITY (Since then her right arm has been bothering her) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.
Around 10 pm I had a dull headache and went to bed. At 12:30 am I awoke not feeling well. I had an upset stomach and a terrible headache. I went into the bathroom and started to put water on my face due to feeling sick. I went to go back to bed and ended up falling back onto the floor with a lightning bolt going through my head. My husband came in helped me to my feet and I started to throw up. Shortly thereafter I had diarrhea. My head was spinning with pain in my head. I got back into bed and had chills and a possible fever. The left side of my body started to swell. I had shooting pains through my left leg and head. I took Tylenol with a big glass of water. It helped a little. The swelling in my neck and left side of my face is still going down as of April 29th.. The swelling caused bruising on my left cheek. I have joint pain in my jaw mainly on the left. It is hard to open my mouth to eat. I have pain in my knees as well.  My neck is still stiff but the swelling is not as visible. I have been getting a dull headache almost daily since the vaccine.
Temp 102, headache, muscle aches, joint aches, no energy- 20 hours
Chest Pain. Tachycardia. Pt discharged with pulse ox for home.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 06/28/2021. PATIENT FULLY VACCINATED ON 04/11/2021.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 28.9 degrees Fahrenheit (-1.72 degrees Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "severe obesity" (unspecified if ongoing); "Iga" (unspecified if ongoing); "nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Large red rash at injection site occurring 8 days after injection. Slight burning sensation around rash.
Vaccine on 1/12/2020. Pt reports minor dizziness after vaccine that subsided. No other associated anaphylactic type rx within 30-60 min after initial vaccine admin. Today 1/14/2021 woke up with right sided HA and now has swelling to her right upper lip. Took Xyzal and symptoms improved. There is no associated hives, rash, trouble breathing or swallowing.
Headache, NauseaVomiting, arm pain, body aches (unspecified) Narrative:
(R) arm red, tender and swollen. Given triamcinolone 0.1% cream x14 days, MOTRIN and ice.
Since about July 26, 2021, I've been experiencing a ringing in my ears. It's constant in my right ear and comes and goes in my left ear. I've spoken to a couple of doctors about it. They prescribed prednisone for two weeks and told me I should speak to my regular doctor if the ringing in my ear didn't subside. The ringing got quieter, but the pitch got higher after taking prednisone. I spoke to my regular doctor. She didn't see anything wrong when she looked in my ears. She sent me to a specialist in November. They did a round of hearing tests. All results were within normal ranges. We're trying to schedule an MRI of my head. As of right now, there is no explanation or source for the ringing in my ears. I wasn't in contact with loud noises and didn't experience any injuries. It's a bit of a mystery right now.
2 month old infant was given Pneumovax 23 instead of the ordered Prevnar 13.
Stuffy nose; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose) and HEADACHE (Slight headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (Slight headache). On 07-Jan-2021, the patient experienced NASAL CONGESTION (Stuffy nose). On 07-Jan-2021, HEADACHE (Slight headache) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  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.; Reporter'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.
5 days after second shot, lover back pain radiating down right leg, two days later shingles rash.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   This case was linked to MOD-2021-395985 (Patient Link).
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was provided.  No treatment medication information was provided.
myalgia; This case was reported by a physician via call center representative and described the occurrence of myalgia in a 76-year-old patient who received Herpes zoster (Shingrix) (batch number 27KF5, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was not recovered/not resolved.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced myalgia since their first dose of Shingrix.  The muscle pain had been present for 5 months after first dose. The patient asked how long do myalgias last after Shingrix injection.  No other information was provided. The reporter did not consent to follow-up.