chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 week old twin (sex not reported) who on 06 Mar 2007 was vaccinated orally with the first dose of Rotateq. At four months of age the child received the first dose of Rotateq. No further information is available. Additional information has been requested.
Patient received pneumococcal vaccine on 02/01/2007 im in left upper arm.  On 02/03/2007 receives and warmth at site were noted.  On 02/04/2007 area of redness is enlarged to 10cm wide and 6cm long with a large fluid filled blister present measuring 5cm wide x2.5cm long seeping serous fluid.  Prednisone ordered on 2/4/07.  Neosporin dressings ordered bid to arm on 02/05/2007.
started itching around 330PM on 9NOV95;started @ bottom of feet & progressed;itches when clothes rub against if scratch then have hives;pt states has taken 2 DPH;advised to see PMD;saw MD in ER cont hives & itching;
10/23/99-Insomnia, ringing in ears, joint stiffness, blurry vision. After 4th Anthrax,forgetfulness, pain on lft arm.
Initial report received from a non-healthcare professional (consumer) on 25 January 2013. A 54-year-old male patient, had received an intradermal dose of FLUZONE ID vaccine from Sanofi Pasteur (batch number and number in series were not reported) on the left deltoid on 11 January 2013. The patient had no medical history and no illness at the time of vaccination. The patient's concomitant medications were not reported. On an unspecified date, few days after vaccination, the patient experienced pain in the joint of his left shoulder. The pain had radiated to acromioclavicular (AC) joint, collarbone, shoulder blade, neck, chest and back. The pain was severe at times. On an unspecified date, the patient felt tired and not himself. There were no laboratory tests performed and corrective treatment details were not reported. As per the reporter, the symptoms had eased a little since they began, but were still present. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.
had a cold recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had a cold recently".  Additional information: A caller was asking for additional medical information if one should wait before they get the new bivalent vaccine if one had a cold recently for the reason that he can not find it on the fact sheet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed pustules on back and chest on 10/24/01. Very itchy, spreading, approximately 225.
pt recv vax 21FEB92 & parent noted swelling, redness, warmth pain to lt upper arm-entire arm from should to elbow on 23FEB;
fever of 101 F; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th August 2020, 1 days after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and woke up at 1am with a fever of 101 degrees F and chills. The chills had resolved at this time, but the fever persists. The reporter consented to follow up. The reporter did not does not had vaccine information for this AE.
I got symptoms of sore throat, ache, runny nose, cough, and tiredness. I did 2 at home test which was positive. I talked to my doctor on 3/28/2022 and was prescribed a Zpac and told me to drink lots of fluids and take OTC cough meds. These symptoms lasted for 4 days.
patient reports that after the 1st dose (2-3 days later) he developed a rash and hives on his trunk and arms.
I feel sick to my stomach; This booster shot, though, has been awful/I started to feel bad; like pretty extreme flu side effects; chills; aches and pains; slight fever; when I fell asleep, I had the most annoying, weird dreams; This booster shot, though, has been awful; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 09:00 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 19Jan2021, when the patient was 20 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 10Feb2021, when the patient was 20 years old, for Covid-19 immunization, reaction(s): "I felt a bit worse after the second shot, but still not too bad", "I felt a bit worse after the second shot, but still not too bad". The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 09:00, outcome "unknown", described as "This booster shot, though, has been awful"; FEELING ABNORMAL (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "This booster shot, though, has been awful/I started to feel bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "like pretty extreme flu side effects"; CHILLS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "aches and pains"; PYREXIA (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "slight fever"; ABNORMAL DREAMS (non-serious) with onset 24Nov2021 17:00, outcome "not recovered", described as "when I fell asleep, I had the most annoying, weird dreams"; ABDOMINAL DISCOMFORT (non-serious) with onset 25Nov2021 05:00, outcome "not recovered", described as "I feel sick to my stomach". Therapeutic measures were not taken as a result of feeling abnormal, influenza like illness, chills, pain, pyrexia, abnormal dreams, abdominal discomfort. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient reported pruritus, shortness of breath, non-productive cough, wheezing and chest tightness.
Information has been received from a physician concerning a 16, 17 or 18 year old patient (high school student) who was vaccinated with a first dose of GARDASIL. Subsequently the patient passed out in the office. It was also reported that after the second dose later in the evening , the patient fainted. The patient's twin was also vaccinated with a dose of GARDASIL and passed out (WAES# 0802USA01476). Additional information has been requested.
psoriatic arthritis to get much worse; I used to have a couple of lesions, now my body is covered with 25 percent lesions.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: "psoriatic arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis to get much worse"; SKIN LESION (non-serious), outcome "not recovered", described as "I used to have a couple of lesions, now my body is covered with 25 percent lesions.".  Clinical Course: It was reported by the patient that the patient received the first two doses for COVID and it caused psoriatic arthritis to get much worse, patient used to have a couple of lesions, now patients body was covered with 25 percent lesions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient with hypertension. Drug Reactions/Allergies were reported as none. On 02-OCT-2014, the patient was vaccinated with ZOSTAVAX vial, 0.65 milliliter, subcutaneous in the right arm. Patient was taking unspecified oral medications for hypertension concomitantly. On an unknown date approximately in October 2014, the patient experienced redness, swelling and bruised area on her right arm, at the injection site after receiving ZOSTAVAX. Lab diagnostic studies were not performed. No treatment was given. The outcome of redness, swelling and bruised area  on her right arm was reported as not recovered. Patient sought medical attention and came back to pharmacy. Product quality complaint was not reported. Additional information has been requested.
EMERGENCY ROOM VISITS WITH CONSULTATIONS WITH NEPHROLOGY AND HEMATOLOGY; REDUCTION OF COUMADIN; NO SOURCE OR REASON FOR BLEEDING DETERMINED AT THIS DATE; HE IS PASSING BRIGHT RED BLOOD WHILE URINATING; NEGATIVE LABS AND IMAGING STUDIES TO DATE.
Information has been received from a certified medical assistant concerning her 35 month old son with seasonal allergy and no past medical history, who on 8/11/03 in the PM was vaccinated IM, also reported as SC, in the left deltoid with a 25 gauge 5.8 needle with a first dose of varicella virus vaccine live (lot # 645171/0330N). There was no illness at the time of vaccination. Concomitant therapy included a dose of Streptococcus pneumoniae vaccine at the same site in the left arm in a different syringe. There were no other concomitant medications. On 8/11/03 the patient's arm became swollen near the shoulder and was tender for a few days. No treatment was required. Unspecified medical attention was sought. The outcome was reported as recovered on 8/14/03. There was no product quality complaint. No further information is expected.
Per patient her hands began to itch and she kept her scheduled appointment with her allergist on 2.8.10.  Her allergist prescribed prednisone. She stated later that day she began itching on her abdomen and noted small raised areas appearing.  The itching didn't stop and later her lower back, posterior of her right arm no further than the bend of her arm and then the anterior of her left leg. She stated the fine papules were located on all affected areas. She treated the affected areas with triple antibiotic ointment, Zyrtec, and hydrocodone.  She did not seek medical care for the additional affected areas other than her hands.  RN examined the affected areas and noted dark discoloration and dried scaly skin. Patient reported the itching had stopped.
Pt recv vax on 10/20/98; 2 wk post vax pt exp flu, bronchitis
Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a five-years-old male patient who received 0.5 mL dose of vaccine DAPTACEL lot C5171AA, expiry date- 23-Mar-2019 via intramuscular route in the left arm on 29-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE; MMR; VARICELLA ZOSTER VACCINE; and TUBERSOL. It was a case of actual medication error due to Expired vaccine used. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Skin allergies. Urticaria. For food, for sun, for perfumes... I've never had allergies to ANYTHING before! I had COVID Arm with the first dose. At the 3rd dose two weeks later I started with skin allergies
Presented to the clinic on 7/28/06 with c/o pain in chest/head. Sensitivity to touch, dizziness when standing up x 5 days and Shortness of Breath times two days. Smallpox vaccination site wnl. CBC and UA done at time of visit and wnl. Tylenol #3 ordered for pain, quarters.
Right arm mild erythema reaction Hep A. Keflex 500 BID, warm soaks qid.
On 1/8/03, pt complained of nausea and extreme fatigue, approx. 3 hours after Typhoid oral administration. On 1/9/03, pt complained of lip swelling and bumps on mouth upon awaking in AM.
anaphylactic reaction; about to black out/lost consciousness; cold sweats; had a hard time /trouble swallowing; turning pale; his pupils were dilated; This is a spontaneous report from a contactable Pharmacist via Medical Information. This Pharmacist reported for two patients, this is the first of two reports regards to a male patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, administered in left arm on 02Jun2021 between 10:00 and 11:00 am, maybe around 10:30ish (Batch/Lot Number: EW0178; Expiration Date: Aug2021, NDC number: 59267100002) as 1ST DOSE 0.3ML, SINGLE for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer suspect. A pharmacist from pharmacy had 2 patients who received the vaccine and both had a reaction after the dose, within one hour after receiving the dose, and EMS was called. The pharmacist confirmed the first patient had the reaction within 1 hour of receiving the dose. She clarified this person was having cold sweats, about to black out, had a hard time and trouble swallowing and was turning pale, his pupils were dilated. Pharmacist explained they make them sit there for 15 minutes after receiving the vaccine so this reaction happened maybe 3 minutes after he got the shot. The EMS came and he was brought to the hospital. The patient did come back afterwards and he said the doctor didn't know 100 percent what happened, but it might been a slight allergic reaction, not to the point where he lost consciousness, but they did release him. She clarified they checked his vitals and everything and released him. When pharmacist was probed for the event, the pharmacist thought it was an anaphylactic reaction. The events require a visit to Emergency Room, patient was brought by EMS. Not had a visit to Physician Office. Unknown if patient received treatment, the pharmacist wasn't be told that much information. The outcome of events was unknown. Causality: In this case, pharmacist did not think so. She thinks maybe it was anxiety but she wouldn't know.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-2021646208 same reporter, product, different patient and similar events.
Redness and itching around site of injection. Onset was a week after injection and is slowly going away.
Chills, body ache, fever. It was terrible. I was in so much pain in my body. Cough, runny nose, and sneezing. I could not use the bathroom or eat. I was living on cold medicine. That persisted for 10 days. On days 11 and 12, I was so dizzy that I couldn't drive a vehicle.
Information has been received from a physician concerning a 69 year old female who on 19-JAN-2007 was vaccinated IM with a first dose of Zostavax (Oka/Merck) (lot # 654603/1405F).  On approximately 19-MAR-2007, 2 months after vaccination the patient developed shingles.  The physician reported that there was sciatic nerve involvement, but it was a mild case.  The patient was treated with VALTREX.  At the time of report, the patient was recovering.  A product quality complaint was not involved.  Additional information has been received from the physician who stated that patient experienced shingles outbreak along sciatic nerve to post knee from buttock approximately 4 months after vaccination (also reported as 2 months).  The patient experienced mild symptoms of pain and it was improving at the time of report.  There was no severe neuropathy.  The patient recovered in one week.  No further information is expected.
Started having severe chills which lasted from about 9:00 PM until noon the next day.
developed urticaria and loose cough 2 days after receiving 1st set of immunizations
Symptoms began 1/26/21 at 1:00am. Severe chills, body aches, joint pain and headache. Lasted until 7pm and then abruptly stopped
The day after patient received the Pfizer 2nd dose he started having symptoms of Shingles.  Symptoms persisted for a week until he was seen by a provider and he was diagnosed with Shingles.
Experienced a rash all over body after vaccine (maybe after 1 to 2 days) and tried Calamine lotion OTC. That didn't work so went to MD and they diagnosed him with vasculitis, had  different severity rashes all over his body and face so they gave him MEDROL Dose pack 9/3/18. He finished the pack and still wasn't better so went out of town and MD gave another MEDROL Pack and betamethasone cream. This helped but rash came back a few days later. MD gave him Prednisone 20 mg starting as 60 mg taper on 9/20/18. The rash is now going away.
Information has been received from a physician concerning a 4-month-old female who was vaccinated with a dose of rotavirus G1 G2 G3 P1 reassortant vaccine live (human-bovine).  The physician reported that the patient subsequently developed a rash.  Unspecified medical attention was sought.  Subsequently, the patient's rash resolved.  Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml (lot # K012424, expiration date 05-JUN-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1008 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Had severe vertigo; This is a spontaneous report from a contactable health care professional (patient). A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9269), via an unspecified route of administration, administered in the right arm on 24Feb2021 at 10:00 as a single dose for COVID-19 immunization.  Medical history included autoimmune disorders and allergy to sulfa both from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (manufacturer unknown); pramipexole (manufacturer unknown); amlodipine (manufacturer unknown); esomeprazole sodium (NEXIUM) and rosuvastatin calcium (ROSUVA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took Augmentin and experienced allergies. The patient previously received the first dose of BNT162B2 on 03Feb2021 at 10:00 (lot number: EN5318) on the right arm for COVID-19 immunization.  The patient did not have COVID prior to vaccination and has not been tested for COVID post vaccination. On 04Mar2021 at 04:30, the patient experienced severe vertigo. The patient went to visit specialists due to the event namely an ophthalmologist and an ENT specialist.  The patient went to the emergency room due to the events and was hospitalized on an unspecified date for two days. The patient received treatment (unspecified) for the events. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event vertigo cannot be excluded. Etiology or diagnosis was not provided; the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Anaphylaxis; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A female patient in her 60's received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension - not certain of medications. The patient's concomitant medications were not reported. Vaccination history included: Ppsv23, for Immunization; Pcv13, for Immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylaxis". The event "anaphylaxis" required emergency room visit. Clinical details: The patient was in early 60's. Patient ended up in ER with anaphylaxis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect PREVNAR 20 may have contributed to the onset of reported event anaphylaxis.  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