chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She's bed bound at home with MS; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced she's bed bound at home with ms (multiple sclerosis) on an unspecified date with outcome of unknown.
Severe headache, Cough,  Nasal Congestion, Loss of smell, Loss of taste, Tiredness
Slowly lost motor skills and had neuropathy. Could not hold food. Down. Fell down stairs and hospitalized for over a month
shortly after injection was provided left arm pain 2:45PM.   6:00 AM Headache 6:00 took Aleve 220mg for arm pain, headache 3:30 PM arm pain, fever, headache, body aches, fatigue 5:30 PM  Aleve 220 mg for symptoms
2-21 11am AFLURIA PFS administered, 3pm sore arm, 8pm windburn, clogged nose. 2-22 5am woke up w/ swollen lips and edema, gums were bleeding - pt also notes Hemoglobin C trait, which affects clotting. 2-22 9am swelling stopped but lip still red.
On May 2nd a 92-year-old customer came in inquiring about the COVID and Shingrix vaccines as a walk-in appointment. He had already received his first Shingrix with us previously. I asked if he had ever received a COVID vaccination previously and he stated that he had not. At the time it was not recommended to give a COVID vaccination and Shingrix within 2 weeks of each other, so I recommended that he receive the COVID shot that day and then his second Shingrix after he had completed the series as it seemed more important at the time. I explained that we had the Moderna vaccine in stock and he agreed to being vaccinated and completed the necessary paperwork again checking off that he had not received any previous doses of a COVID vaccine and that he did not have any reaction to any previous doses of a COVID vaccine. He returned to the pharmacy about a week later stating that the first dose had "wiped him out." He was feeling better when he came in, but he stated that his doctor recommended that he not complete the series, so I cancelled his second dose of Moderna at that time. Yesterday the pharmacy manager called him to schedule a time for his second Shingrix dose as he was on our list, and at that time he informed the pharmacist that he had received one dose of the Pfizer vaccine back in February and it had "wiped him out" and so he came into our store in May and received the Moderna vaccine. I called the patient to clarify the situation this morning as I had asked him multiple times when he came in in May if he had received any other vaccinations, and he stated that he had made an error in not telling me and clarified it with the pharmacist yesterday. He stated it is now a "non-issue" for him and does not want me to notify his PCP. He is seeing him in a couple of weeks and informed me that he would notify him at that time. In the end the patient received one dose of Pfizer in February and one dose of Moderna in May 2nd.
5 hours after flu shot developed acute burning in throat, swelling of tongue and under tongue, and gums. No shortness of breath. Today (the next day) still has sore throat and swollen tongue and gums (false teeth not fitting) and palate
Pt rec'd 2nd dose of Anthrax 9 days after 1st dose (prior to next scheduled dose).
Pt had severe onset of symptoms within 12 hours of vaccination. Symptoms of myalgia, malaise, joint pain, cough, sore throat, fever of 103', hives at the injection site, and an eruption of her cold sores in mouth and nose that were unresponsive to valacyclovir. These last for 24hrs and then were resolving. Three days later they returned at the same intensity as originally, they resolved after another 24hrs. The cough continued and was still active to date 12/18/19.
I conceived and became pregnant about the 20th of September, 2021.  I received my second Maderna vaccine on the 28th of September.  When I went in for my first prenatal visit on October 22nd, at around 7 weeks pregnant, the physician had difficulty detecting a heartbeat, but a pregnancy was confirmed and a followup ultrasound was scheduled for the following week.   On October 27 a low fetal heartbeat was detected and I was classified as a high risk pregnancy and close monitoring was ordered. I returned to see the doctor on November 8 at 9 weeks pregnant, and at that visit it was determined that the fetus had stopped progressing and the pregnancy was likely no longer viable, but a followup visit was scheduled to...  to allow time for my body to naturally miscarry.  My body never naturally expelled the pregnancy and I ultimately underwent a manual vacuum aspiration procedure to end the pregnancy on November 22, 2021.
FOLLOWING THE VACCINATION, PATIENT REPORTED A PAIN THAT DID NOT RESOLVE WITH MEDICATIONS (IBUPROFEN AND HYDROCODONE). PATIENT REPORTED TO THE PHARMACY ON 11/10/23 TO COMPLAIN ABOUT THE PAIN THAT DID NOT RESOLVE.
Patient stated her "blood work went crazy" and she began to experience noticeable, extreme fatigue
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/06/2021 and 4/01/2021. Covid + 2/6/22. Presented to ED 2/9/22 w/worsening SOB. Admitted for acute hypoxemic respiratory failure 2/2 Covid PNA, COPD exacerbation and AFib. Was on HFNC 90/60 and also had worsening delirium and confusion. Respiratory status became more labored through admission. Transitioned to comfort care/DNAR. Treated with DuoNeb, remdesivir, cefepime, and decatron. Patient last received Tocilizumab for RA 4mg/kg on 1/28/22. Patient expired 02/13/22.
3 nights woke up feeling delirious, involuntary movement of tongue/dyskinesia, inflammation of sublingual gland (mouth), spasm (mild) sides of jaw and neck.
got Flu shot but still sick; Initial information was received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional via social media.  This case involves an unknown age and  gender patient who got flu shot but still sick , after receiving vaccine Influenza vaccine.  The patient's medical treatment(s), vaccination(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (formulation, strength, dose , route and lot number :not reported ) in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of got flu shot but still sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported, patient got Flu shot but still sick; shots jokes.   It is unknown if there were lab data/results available. Was the company suspect product inappropriately used as per local Marketing authorization? Unknown  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.    Outcome: unknown
4NOV97 & 6NOV97 c/o arm red, hot to touch w/redness the size of a popcorn;states feels squeezing advised to apply cool compress, poss DPH;
There was no adverse event. Patient can in for his Pfizer Booster on Nov 1, an expired dose of vaccine was given. Patient was contacted about the event and came back on Nov 3 for another Pfizer Booster
I never had anything else wrong. It was within couple days I was feeling way too tired and said oh it was the vaccine. I didn't do anything and kept on dragging things. I was tired all the time. And I went back to being the same. I was never a lazy person. July 15 - March 15. After the appt I went back to being myself.
at injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via Agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  This case is linked to cases 201905317, 201905318, 201905319, 201905320, 201905321, 201905322, 201905323, 201905324, 201905325 due to same reporter.  Follow up received from other health professional via Agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company Comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Information has been received from a licensed practical nurse concerning her 11 year old daughter who on 14-JUN-2007 was vaccinated with a varicella virus vaccine live (Oka/Merck) via intramuscular route. Concomitant vaccination included tetanus toxoid. The patient experienced injection site pain which was being treated with acetaminophen and cold compresses. The patient's injection site pain persisted. No product complaint was reported. Additional information has been requested.
Patient states he got an injection on Tuesday for shingles. And then yesterday he had a procedure done on his eye. Then yesterday afternoon started feeling bad, al major muscles aching, really tired, and feeling puny. this morning he noted a large lump on the collarbone, and the arm is very sore where he got the shot. But this lump is near the collarbone area and appears to be a lymph node, its very sore to touch. There is no redness, he denies fever/chills
May 20 Had felt "fatigued" most of day - attributed it to having to rise earlier than usual and having not slept well. Evening of 2nd dose date I began to feel somewhat more fatigued. (Had also drank a shot of tequila before dinner and had a glass of white wine with. Was also smoking high quality cannabis in moderation.) At 11:00 pm I rose from my chair having been seated for probably an hour and symptoms hit me full force: chills, the mild soreness in my upper arm became moderate to severe and spread to my shoulder and lower back, whole body particularly joints (including fingers of left hand) aches, mild nausea. Rough night May 21 Symptoms continue with less severity. Especially notice pain in lymph gland areas - armpits, lower back, sides of neck. by evening (with the help of 1/2 Percocet (10/325) I was feeling ok and stayed up til 1:30am May 22 Awake @ 8am. whole body particularly joints still ache including left hand (exacerbated by phone use). Upper left arm & shoulder still sore but mid-back left side more so. May 23 Pretty much back to normal. "Flu symptoms" ran their course. Still have a tough immune system at 73yo apparently (I rarely get sick at all)
Dizzy; Legionnaire's disease; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4379945-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1159670) at unk (citrate free) and second regimen since Aug2021 (Lot number: 1159670), all subcutaneous for psoriasis. The patient's relevant medical history included: "Moderate to severe chronic plaque psoriasis " (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single via Intramuscular), administration date: 02Feb2021, for COVID-19 immunisation. The following information was reported: PNEUMONIA LEGIONELLA (medically significant) with onset Jun2021, outcome "unknown", described as "Legionnaire's disease"; DIZZINESS (non-serious), outcome "recovered", described as "Dizzy". On 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation  The reporter's assessment of the causal relationship of "legionnaire's disease" and "dizzy" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Legionnaire's disease, dizzy cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rash burning red spots on neck; Burning red spots on neck; This is a spontaneous report from a contactable consumer or other non HCP.  A 35-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 24May2021 DOSE 2, SINGLE for covid-19 immunization. The patient medical history included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient received other medication in two weeks included body scrub. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in May2021, the patient experienced rash burning red spots on neck (rash) and burning red spots on neck (rash macular) for 4 days post shot. The clinical outcome of rash and rash macular was recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number could not be obtained. No further information is expected.
In bed all day with aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (In bed all day with aches), PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 0ZZMZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Apr-2021, the patient experienced PAIN (In bed all day with aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (In bed all day with aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medications and treatment medications were not provided.  The patient received her second shot on 18MAY2021. The next day the patient was in bed all day with aches, fever and chills.
We discovered that patient received a Moderna vaccine 2 months prior to her 18th birthday. She reported no adverse effects.  She was informed that Moderna Covid vaccines have not yet been approved for those under 18 years of age.  She expressed that she strongly wished to receive her 2nd dose of Moderna prior to her 18th birthday.  She was informed that she should delay until her 18th birthday unless Moderna gained approval for their vaccine for her current age group prior to her 18th birthday.
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. In 2015, the patient was inoculated with 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. In 2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. 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. The outcome is unknown. Additional information has been accepted.
Dizziness, Fever, Tachycardia, injection site pain Narrative:  Other Relevant History:
Caller stated that she received her vaccine on 01/25/2021 and her right arm has been sore and swollen since.
After vaccination, a reconstitution error was discovered, the vaccination received was slightly more concentrated. The employee has been contacted, made aware of the incident, educated on reporting signs and symptoms.
Received tdap (L) arm 1-18-13 next day arm swelled reported back 1/23/13 arm very painful, hard & swollen woke up with tingling, numbness sensation in (L) hand. Taking MOTRIN for pain. 1-24-13 (L) arm deltoid/deltoid 3" bigger than (R) 12x10 cm hardened area 7 x 7 c, erythematous still sore.
LOCAL CELLULITIS WITH PUSTULES AND SATELLITE PUSTULES AT VACCINATION SITE. AFEBRILE.  TREATMENT: KEFLEX 250 MG PO QID FOR 10 DAYS MOTRIN 800 MG PO TID PRN PAIN LIGHT BREATHABLE BANDAGE, CHANGE DAILY. F/U IF WORSENING.
SEVER LOWER BACK AND NECK MUSCULAR PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021 07:30, the subject experienced sever lower back and neck muscular pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sever lower back and neck muscular pain. This report was non-serious.
Felt dizzy, hives, chest pain/SOB; taken to hospital, .5 epi IM, 50 Benadryl IV, 125 mg solumedrol IV
Information has been received from a physician concerning an 13 year old female patient with overweight and no past medical history, who on 26-AUG-2010 was vaccinated with the first dose of GARDASIL (dose not reported, lot # 666121/0597Z), and the second dose of VARIVAX (Merck) (dose not reported, lot # 665038/1044Y). Concomitant therapy included ADACEL (Lot number C3249AA), and MENACTRA (Lot number U3339AA). On 26-AUG-2010, the patient fainted shortly after administered GARDASIL. "The patient came to and the nurse took the patient's blood pressure, then the patient fainted a second time." The patient's blood pressure was 106/71 and eye refraction of 20/40. "The office called 911 and the patient was taken to the emergency room and was given an IV to replenish fluids (not specified)." "The nurse mentioned that the patient is overweight and did not eat before she received her vaccinations." The patient was not hospitalized. The patient did not have a follow-up visit with the physician at the time of reporting. The patient's outcome was unknown. Additional information has been requested.
I was just diagnosed for the 3rd time with Covid; I was just diagnosed for the 3rd time with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing) notes: Hard time breathing; "M.S." (unspecified if ongoing); "Lymes" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Chemo for Breast Cancer" (unspecified if ongoing), notes: Ended a five-year Chemo for Breast Cancer.; "Chemo for Breast Cancer" (unspecified if ongoing), notes: Ended a five-year Chemo for Breast Cancer. 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 "I was just diagnosed for the 3rd time with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I was just diagnosed for the 3rd time with Covid.  Clinical information: Patient was in need of help from Covid. Hard time breathing. Had Asthma, M.S., Lymes, Fibromyalgia, Osteoarthritis. And just ended a five year Chemo for Breast Cancer. She was just diagnosed for the 3rd time with Covid. She have had both Vaccines and 1 booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After vaccinating patient, the injection site immediately began to swell in a lump. I advised the pt to take BENADRYL and when I called several hours later she said it had stabilized.
Patient's mother reports 3 x 4 cm red oval raised area on back of right arm in area of VZV vaccine given 10/19/07. No other problems reported