chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM; MILD NAUSEA; DIZZINESS; LOW ENERGY; FELT LIKE FLU SYMPTOMS; FELT MISERABLE; DID NOT SLEEP THAT NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 09:15 am for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021 17:00, the subject experienced sore arm. On 05-MAR-2021 17:00, the subject experienced mild nausea. On 05-MAR-2021 17:00, the subject experienced dizziness. On 05-MAR-2021 17:00, the subject experienced low energy. On 05-MAR-2021 17:00, the subject experienced felt like flu symptoms. On 05-MAR-2021 17:00, the subject experienced felt miserable. On 05-MAR-2021 17:00, the subject experienced did not sleep that night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, mild nausea, dizziness, felt like flu symptoms, and felt miserable on 07-MAR-2021, low energy on 08-MAR-2021, and did not sleep that night on 06-MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Patient has redness, itching at site of injection, saucer size, still evident on 11/2/11.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2011, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt recv vax on 4/5/99; on 4/6/99 pt exp edema/ erythema of LA; tx=hot/ cold packs, Childrens Tylenol
2-3 hours after injection, just muscular pain at joint site injection that worsened to be mild-moderate over next 14 hours. 8 hours after receiving injection, developed mild global headache. 14 hours after receiving injection, developed chills/shivering and temperature was 100.0 F. Took 1000mg acetaminophen and symptoms improved after about 45 minutes. 8 hours later only mild headache and fatigue, with mild-moderate left deltoid discomfort. All symptoms improved significantly after another 1000mg dose acetaminophen. Currently 26 hours post injection, and feeling no need to present for evaluation as I expected these side effects.
2-3 days after flu injection. Client has increased left joint pain, decreased ROM. Pain level 2/10. Pain progresses to 9/10 by 10.17.2016 with continued decreased ROM. Client is taking TYLENOL 500mg x 2 tab SIB and Tramadol 50 mg 2 tab BID for past 3 days.
Dizziness/light headed. Headache. Nausea. Diarrhea. Abdominal pain. Body & muscle aches. Weakness.
Went on 1/18/16 in the afternoon to employee health received Hep B in upper (R) arm couple hours later had the following tingling legs, arms, headache, blurred vision, burning throat, chest pain, difficulty breathing, fever, cough.
Patient fainted approximately 2 minutes after administration of Moderna vaccine.  Patient was seated in chair and came too within 1 to 2 minutes.  Patient did not require further treatment. Patient had a history of passing out on previous vaccinations.
Patient reported dizziness. Was with sister.  ALS assessed, hypotension determined.  Transported ALS to Hospital [Run #39684, Transport #39722]
Breakthrough case admission after 2 vaccines Pfizer x2; Pfizer 6/3/21 lot# EW0179;  Pfizer 6/24/21 Lot# EW0179
I have always had minor psoriasis, about 5 days after the first Pfizer vaccine I had a full scalp psoriasis issue. Had to shampoo with coal tar shampoo to get it to go away; This is a spontaneous report from a contactable consumer. A 61-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 61-years-old) at 15:00 as a single dose for COVID-19 immunisation. Medical history includes psoriasis and ovarian cysts. Concomitant medications included ramipril 2.5 mg once daily (MANUFACTUERER UNKNOWN), folic acid 1mg once daily (MANUFACTURER UNKNOWN), calcium magnesium citrate 10 ml twice daily (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN) 2000 units twice daily, CoQ10 200 mg once daily (MANUFACTURER UNKNOWN), MSM 1000mg once daily (MANUFACTURER UNKNOWN), EFA twice daily (MANUFACTURER UNKNOWN), multivitamin once daily, (MANUFACTURER UNKNOWN) claritin once daily (MANUFACTURER UNKNOWN), budesonide (MANUFACTURER UNKNOWN), albuterol (MANUFACTURER UNKNOWN), azestiline (MANUFACTURER UNKNOWN). Patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent nasal swab test (for COVID-19) on 12Mar2021 and the result was positive. On 07Mar2021, the patient experienced minor psoriasis and approximately after five days of vaccination, the patient had a full scalp psoriasis issue. Therapeutic measure for the adverse event included the use of a coal tar shampoo. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of psoriasis was recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
Arm started hurting while asleep.  Woke me up when I laid on it.  Arm swollen, red, rash, very painful.  Had nothing for 8 days after initial vaccine. Used pain patches, took extra strength Tylenol.  Lasted 2 1/2 days.  A little redness has continued.
Localized swelling and erythema approximately 6x6cm left arm. Treat with cold compresses and topical hydrocortisone.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond 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 (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    No concomitant information was reported. BUD reported as 17Feb2022. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live non-significant follow-up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Vertigo; It was like she was being shaken; She got sick; Threw up; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL1283, Expiry Date: Unknown) via an unspecified route of administration in left arm on 02Feb2021 at 09:45 (at the age of 63 years-old) as dose 1, single for COVID-19 immunization. Patient medical history included ongoing Cancer (neoplasm malignant, patient medical comments reported as multiple sclerosis), sick, helps not to throw up (vomiting), Heartburn (dyspepsia) from an unknown start and stop date. The concomitant medications included dexamethasone acetate (DEXAMETHASONE ACETATE) taken as a real small dose 0.25mg once a day for sick and helps not to throw up from an unspecified start date and still ongoing, omeprazole sodium (OMEPRAZOLE [OMEPRAZOLE SODIUM]) taken as a dose of 20mg twice a day for heartburn from an unspecified start date and still ongoing, talazoparib tosylate (TALZENNA) taken 1mg a day for indication Cancer from an unspecified start date and still ongoing. The vaccination facility type reported as hospital and vaccine were administered at military facility. Additional vaccines administered on same date of the pfizer suspect was reported as none. No Prior Vaccinations within 4 weeks and adverse events following prior vaccinations. About 2 weeks after the first dose patient experienced an episode of vertigo, it was coming out of the blue. She was sitting down and then all of a sudden it was like her head and world was tilted. It was like she was being shaken. This only lasted for like a minute. She got sick and threw up from this on 17Feb2021 at 7:30. She spent the rest of the day trying to take it easy. By the end of the day, she was fine. she has never had vertigo before and wanted to know if caused by the shot. Stated due to this event she was scared to get the second shot. Patient is asking these symptoms to be a result of vaccination, should she have waited longer before calling to see if symptoms would have resolved on their own. No investigation assessment was done. The patient taken second dose of vaccine in left arm on 23Feb2021 at 9:30. The patient was not visited to physician office visit and emergency room for the events. Stated she has cancer, and she has not been seen by her regular doctor She sees her oncologist. She was also being treated for cancer (not chemotherapy), but she had stated that usually the pill does not bother me at all. The clinical outcome of all events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after three doses Moderna 2/6/21 Lot# 013M20A;  Moderna 3/6/21 Lot# 030A21A;  Moderna 11/2/21 Lot# 939905
6mins post vaccination pt c/o "hot throat" having a "hard time breathing" Vitals: 09:55 122/70, 76, 18 -- > 10:05 120/69, 76, 98%  Lungs clear, no wheezing, no additional symptoms. Pt reports feeling better after vitals.  Pt given water. Pt stable and released from the vaccination site @10:10
Chest pain, heart beating fast, heart palpitations, hard time breathing and getting light headed and dizzy. Seen my doctor and was placed on a heart monitor, had an echocardiogram and will be doing a stress test.
SORENESS IS ABOUT A 2 FOR A DAY AFTER; NEEDLE PAIN IS MINOR; FEVER GOT UP TO 103; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced soreness is about a 2 for a day after, needle pain is minor, and fever got up to 103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever got up to 103, and the outcome of needle pain is minor and soreness is about a 2 for a day after was not reported. This report was non-serious.
Joint pain last week of December 2003. Fever, chills, loss of appetite, generalized weakness and discomfort. Syncope episode 1/12/04. Coughed up blood 1/13/04. Hospitalized 1/14 for respiratory failure. Vent   15th. Died on 1/18/04. Death certificate reads intractable pulmonary hemorrhage. Discharge Summary received on 6/14/2004 states agitation, restlessness, hypoxia, and tachycardia.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. The Nurse reported for two patients. This is the 1st of two reports. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced skin sensitivity, bodyache, nausea and local reaction, assessed as non-serious, non an unspecified date with outcome of unknown. Follow-up (19AUG-2016): Follow-up attempts are completed. No further information is expected.
pt stated about a week after getting the covid booster her blood pressure started going up.  It was higher than normal so she went to her doctor and had it checked and it was around 138/84.  It reached 162/90.  Her doctor recommended her to exercise more and lower sodium intake.  She is tracking it daily now.   She had her pneumonia and flu vaccine around the 3rd week in December.  She developed shingles on 1/2/22 but has never had chicken pox.   Her BP is still fluctuating up and down averaging 138 to148/78-87 and normal is 118/76.
This spontaneous report was received from a currently 64 year old female patient via a company representative. Concomitant medications included amlodipine, metformin and losartan. Concurrent conditions included high blood pressure.  Drug reactions/allergies inlcuded aspirin and hydromorphone (DILAUDID).  Sometime in 2014, the patient received ZOSTAVAX to prevent shingles (route and lot # not provided).  The patient reported since having the vaccine, she had the shingles three times and all three times developed an itchy rash on the left side of her face.  First onset was in the "Spring of 2015".  During the second bout of shingles (date unspecified), she went to the Emergency Room (ER) because the shingles virus had spread and irritated her left eye.  Her last episode of shingles was in February 2017 (reported as about three weeks ago).  All three episodes were treated with the same unspecified "7-day" medication.  She did seek medical attention described as "yes, doctors office visits".  The patient present status was recovered.  The patient was seeking compensation for treatment received at doctor's office and also the ER visit. Additional information has been requested.
bump; itching; Red spot 2 inch diameter; Left arm sore with bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter) and VACCINATION SITE PAIN (Left arm sore with bump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Left arm sore with bump). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter). At the time of the report, VACCINATION SITE MASS (bump), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red spot 2 inch diameter) and VACCINATION SITE PAIN (Left arm sore with bump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment reported was Tylenol #3.; 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.
Hardness in the pit of my stomach within a couple of hours that felt like a stomach virus. I took a Pepcid AC tablet to see if it would help, and it did relieve the problem within the hour.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Pharmacist states patient is showing symptoms of shoulder bursitis
headache; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced headache (non-serious), after getting the first dose. The clinical outcome of the event was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162115 same patient, different vaccine dose number and event;US-PFIZER INC-2021162298 same patient, different drug and event
consumer reports that 2 children exp adverse event following 1st DTP @ 2mons of age; pt exp a fever & high pitched crying for 3 hrs; event occurred in 1989; pt recovered; no sequelae; pt had hx of apnea; subsequent DTP doses were not given
Head to toe rash with hives all over body scratchy  and itchy with itchy throat. I was already pre-medicated with dexamethasone and benadryl.
Muscle cramps in calves, feet, thumbs; Thumbs lock up; Extremely painful; The patient received both doses on 10Aug2021; This is a spontaneous report from a contactable consumer (patient). This 44-year-old non-pregnant female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Aug2021 at 10:00 (Lot number and expiry date: not reported, at the age of 44 years) as single dose and she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm (left shoulder) on 10Aug2021 (Lot Number, Expiry Date: not reported, at the age of 44 years) as single dose for COVID-19 immunisation. Medical history included orthoarthritis and COVID-19 (from an unknown date and unknown if ongoing). There were no concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications that the patient received within 2 weeks of vaccination. The patient received both doses on 10Aug2021 (inappropriate schedule of vaccine administered). On 16Aug2021, the patient experienced muscle cramps in calves, feet, thumbs similar to a 'charlie horse' and extremely painful. Every time, she stretched she would get one at least in one of her calves. Thumbs lock up a lot too. Hospitalization was not prolonged. Treatment was not received. The adverse event result in following Doctor or other healthcare professional office/clinic visit. Location of injection for vaccine received same date: Pfizer was left shoulder. It was reported that reason for batch/lot is Unknown was misplaced/discarded. Device Date was 10Sep2021. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
little bit of the needle left out/ didn't go all the way into the arm; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (little bit of the needle left out/ didn't go all the way into the arm) 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 an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (little bit of the needle left out/ didn't go all the way into the arm). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (little bit of the needle left out/ didn't go all the way into the arm) outcome was unknown.     Reporter reported that needle went into fat (into muscle). No concomitant drug reported. No treatment information was provided by the reporter. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up appended, contains no new information.
1st dose  in November 2021, late for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose in November 2021 ).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was 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: 10-MAY-2022 Reporter's comment: A pharmacist reported that the patient was late for the 2nd dose. The health care professional was working from home and did not have patient date of birth or vaccination date and information available at the time of report. The health care professional declined to have his information stored in GlaxoSmithKline database but did consent to follow-up via postal mail. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.