chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempt to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report refers to a 15-year-old patient of unspecified gender. It was unkonwn if the patient had any allergies, conditions or illnesses at the time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the second dose of GARDASIL (intramuscular injection, batch/lot# J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 04-FEB-2014 at 4:00 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 4:00 PM). The patient was going to return to revaccinate at no charge. No adverse event was reported for the patient. Outcome was not reported by the reporter, although date of recovery was written as 27-MAR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
uterine cramps; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 35-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm right on 11Feb2021 14:45 (at the age of 35 years) SINGLE for covid-19 immunization. Medical history included GERD, depression, anxiety, PTSD from 11Feb2021 to an unknown date, food allergy from an unknown date and unknown if ongoing Walnuts and cashews. The patient concomitant medications were not reported. Patient was not priorly did had covid vaccination and was not covid tested post vaccination. Patient took medication Mirena IUD in two weeks before vaccination and no other vaccine in four weeks. On 11Feb2021 14:45 the patient experienced sudden onset of uterine cramps within 10 minutes of receiving the shot. Might not be related but wanted to report anyway. Patient received Advil as Adverse event treatment. The outcome of the event was recovered on unspecified date of 2021.    Follow-up attempts completed. No further information expected.
This spontaneous report was received from a nurse practitioner via company representative referred to one or two infant patients of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, one or two patients were vaccinated with ROTATEQ vial (strength, dose, lot # and expiry date were not reported) orally for prevention of rotavirus gastroenteritis. The reporter reported that one or two patients choked (medically significant) while taking ROTATEQ in the nurse practitioner's office. The patient(s) did not spit out the ROTATEQ. The patient(s) sought medical attention for the event. It was unknown if treatment was given for the event or if lab diagnostics or studies were performed. The outcome of choking was recovered/resolved. The causality assessment between the event choking and ROTATEQ was not reported. No further information was reported. There was no product quality complaint (PQC) reported. Upon internal review, the event choking was considered to be serious due to medically significant.
Patient had absence seizure immediately following dose.  Patient has history of seizure of this type and kind at this time of day (mom says has one every evening around this time).
(1) Hard to breath. (2)  Vision is foggy but she cans still see.
Patient did not receive full vaccine on date of service, two bottles of diluent were drawn together and administered.  Provider will work with Manager to counsel team member who administered dose and additional enforcement of the double check before vaccines are administered will be implemented.
This is a spontaneous report from a contactable nurse (patient) via a Pfizer sales representative. A 65-year-old patient of unspecified race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, in Jul2015, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at injection site and limitation of arm movement both in Jul2015 with outcome of recovered after 12-24 hours.
On 1/9/2021 started to have Postural Orthostatic Tachycardia  Syndrome and PVCs associated with SOB and chest tightness and not recovered yet.
Redness, itching, irritation spreading approximately 2-3 inches beyond site of injection. Treated with cephalexin and prednisone.
They are having twitching and pulsating mainly in the legs and sometimes other parts of the body; taken a toll emotionally; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, No event reported.), for COVID-19 Immunization, reaction(s): "Did not experience any side effects after their first dose". The following information was reported: MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "They are having twitching and pulsating mainly in the legs and sometimes other parts of the body"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "taken a toll emotionally".  Additional Information: The reporter stated his wife, and 2 daughters and one son. reporter stated his son and himself have both received "both Pfizer vaccine doses and have had no side effects at all."  His wife and one daughter had both Pfizer vaccines and one daughter has had only one dose of the vaccine.  The four family members received their 2nd Pfizer vaccine dose 3 weeks ago and this is when his youngest daughter received her 1st Pfizer vaccine. The reporter stated he was very concerned about the side effects his wife and 2 daughters are having daily. They are having twitching and pulsating mainly in the legs and sometimes other parts of the body. This occurs frequent and infrequently depending on the time of day. The reporter stated that they waited to see if it would subside or improve, but it was persisting, and they are concerned. The reporter stated he was not sure if it was a genetic type of issue. The reporter stated they have read all information and have been seen by their PCP for these symptoms and the HCP replied not to worry and it will go away. The reporter was asking why these side effects are not listed on the info sheet about side effects. There has been no progress in the past 3 weeks, as far as decreasing symptoms. It had taken a toll emotionally and physically on them, this has affected their lives.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021749501 same reporter/drug/event, different patients.;US-PFIZER INC-2021749502 same reporter/drug/event, different patients.
04/24/2021 DELIVER DATE 8LBS 9 OZ BABY BORN AT 41 WEEKS AND 1 DAY SPONTANIOUS LABOR ENDED IN C-SECTION DUE TO DISTRESS MECONIUN ASPIRATION SEVERELY IN NICU FOR 18 DAYS. EXCESS BLEADING AFTER DELIVERY , REQUIRED GENERAL ANESTHESIA
2day p/vax pt devel rash which appeared to be viral exanthem probably due to rotovirus
Patient c/o a tingling in lips and rash over arm. Patient taken immediately to ER to be seen.
No additional AE reported; VAQTA was inadvertently administered on 13 APR202 l after a temperature excursion occurred; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.    On 13-APR-2021, the patient was inadvertently vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot # T033304 has been verified to be a valid lot number, expiration date reported as 23-JUN-2022, however upon internal validation established as 02-APR-2022; strength, dose, frequency, route, anatomical location were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to a temperature of 9.0 degree Celsius for 10 hours 56 minutes and 0 seconds. There was no previous temperature excursion for the vaccine. The digital data logger was involved. No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA003768: US-009507513-2104USA003782: US-009507513-2104USA003622: US-009507513-2104USA003606:
Alteration of allergy symptoms; Severe pain in the joints; Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Alteration of allergy symptoms), ARTHRALGIA (Severe pain in the joints) and VACCINATION SITE PAIN (Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient's diet was broad. He is strong.  Concurrent medical conditions included Hypertension.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Alteration of allergy symptoms), ARTHRALGIA (Severe pain in the joints) and VACCINATION SITE PAIN (Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses). At the time of the report, ALLERGY TO VACCINE (Alteration of allergy symptoms), ARTHRALGIA (Severe pain in the joints) and VACCINATION SITE PAIN (Pain in the left elbow and inability to make heavy efforts, this arm was where they applied the two doses) outcome was unknown.      No concomitant medication details were provided. No treatment medication details were provided.   Patient two months ago got the second dose of the modern vaccine and began to observe unwanted effects.  Reporter would like to be guided on what to do to eliminate intense pain in the elbow and how or what to do to eliminate the general pain.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2021-619952 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-619952:wife case
Pt recv vax on 3/16/99; on same day pt exp red/ itchy/ warm rt arm vax site, fever; 3/19/99 pt exp erythema rt arm vax site; dx=cellulitis, allergic rxn; tx=Keflex, Benadryl
fever of 104.0, aches & pains, h/a, dizziness, insomnia, localized muscle soreness in inj site;these sx lasted 2 days till pt recovered;
Soreness in left arm (10/19/13 - present) Boil/pain at injection site Fatigue and flu-like achiness arms/legs Generalized overall feeling of inflammation.
I sat for 30 mins after the vaccine at the doctors office.  When I got home I started feeling my heart beating and started feeling like my body was raising. After 10 mins I checked my BP 140/90 which is high for me.  I took a BP pill.  It took a couple of hours for it to come down to normal. Went to sleep and woke up BP normal and a slight headache.  My arm was sore lasting about 3 days.
lost strength in both his feet; loss feeling in his left side of the body mainly; Tongue swelling; couldn't breathe; weakness of left facial area, arm and leg; tightness of neck; Bells Palsy; drooling/saliva on his pillow when he sleeps at night; nauseous; A spontaneous report was received from a health care professional concerning a 52-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed loss of feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, drooling, and nausea.     The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported.   On 25 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Mar 221, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, patient experienced nausea and couldn't breath, lost strength in his left face, arm, leg, developed Bell's Palsy, and suffered from  droopiness of the face a bit and drooling/saliva on his pillow when he sleeps at night.   On 01 Mar 2021, the patient developed developed loss feeling in his left side of the body mainly, had tongue swelling, and lost strength in both his feet .  Treatment for the event was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, loss feeling in his left side of the body mainly, had tongue swelling, couldn't breathe, lost strength in both his feet, Bell's Palsy, and nausea, were considered unknown. The outcome of drooling was not resolved.; 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.
Gum pain, gland pain in the face, leg pain, a little of feeling of suffocation.
Within seconds of receiving the vaccine, I had a strong metallic taste in my mouth. My husband and I sat in our car for the 15 minutes required and I thought I was feeling a bit off, but also was trying to figure out if anyone else had experienced the metallic taste. After our 15 minutes wait period, we left to head back home. On the way home, about 30-40 minutes after I received the vaccine, I started to feel really warm. Then my neck started to feel really hot and when I swallowed it felt like I had a knot in my throat. As far as I know, I'm not allergic to anything, but realized there was something seriously wrong with my body and had my husband get off the freeway so I could get some water and possibly go to an urgent care. It also doesn't help that my heart was racing and I started panicking because it felt like my throat was starting to close up. When the initial anxiety of what was happening calmed down, we carefully drove home and I called the urgent care nurse line at my doctor's office. The nurse on the line told me to take a Benadryl and to take another one 6 hours later. He said that I was having an adverse reaction and if things got worse go into the ER . Luckily things calmed down after a while but the metallic taste stayed for two days. I've been advised to not get the 2nd dose, which I'm honestly not comfortable getting at this point either.
Problem with my skin started just few days after i had my second covid vaccination; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISORDER (Problem with my skin started just few days after i had my second covid vaccination) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg strength at an unknown loading dose. On an unknown date, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On an unknown date, the patient experienced SKIN DISORDER (Problem with my skin started just few days after i had my second covid vaccination). At the time of the report, SKIN DISORDER (Problem with my skin started just few days after i had my second covid vaccination) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient started treatment with DUPIXENT for about 4 months. Patient thought that Dupixent was knocked out of system. Patient had skin issue started just a few days after second covid vaccination. His hands were extremely bad for a year and a half. Tried everything in the world, every cream, had steroids, nothing working. At the time patient thought Dupixent was knocked out of system. After a few weeks of Dupixent, they have cleared up and have been cleared up for some time now. Patient's last dose of Dupixent was on 01-Feb-2023. At the time of the report, Dupixent was discontinued.
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Seizure-Severe, Additional Details: Patient stated that she had no issues with the first dose.  About 2-3 minutes after receiving the second dose she began having convulsions and hitting her head on the wall.  Her Father and I were able to get her to the floor then convulsions stopped. The paramedics arrived and took her to the ER for further evaluation.
Neuropathy pain; tinnitus; nausea; swelling at injeciton site; This case was reported by a pharmacist via call center representative and described the occurrence of neuropathic pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number N4C23, expiry date 15th November 2021) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced neuropathic pain (serious criteria GSK medically significant), tinnitus, nausea and injection site swelling. On an unknown date, the outcome of the neuropathic pain, tinnitus, nausea and injection site swelling were unknown.   It was unknown if the reporter considered the neuropathic pain, tinnitus, nausea and injection site swelling to be related to Shingrix.  Additional details were received as follows: The patient was experiencing tinnitus, neuropathy pain, swelling at injection site and nausea.
sore arm, sore throat, feeling congested, period and period symptoms for 2 weeks
Bright red spots appeared next day, first on left forearm, now appearing on right forearm/ Few pin pricks of red appear on left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Oct2021 14:00 (Lot number: EW0191) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "asthma", start date: Mar2017 (ongoing), notes: asthma (current), Qvar 80 mcg 2 puffs 2x/day; "known allergies: penicillin" (unspecified if ongoing); "IBS" (not ongoing), notes: ibs (recovered); "celiac" (unspecified if ongoing); "chronic fatigue" (not ongoing), notes: recovered; "known allergies: shellfish" (unspecified if ongoing); "known allergies: dairy intolerance" (unspecified if ongoing); "celiac (gluten)" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 01Oct2021; QVAR taken for asthma; VIT D3; FOLATE; CLARITIN [LORATADINE]. Past drug history included: Macrodentin, reaction(s): "known allergies: macrodentin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 12Mar2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "Blood spots, bright red under the skin of my left forearm", "shingles". The following information was reported: ERYTHEMA (non-serious) with onset 2021, outcome "not recovered", described as "Bright red spots appeared next day, first on left forearm, now appearing on right forearm/ Few pin pricks of red appear on left arm". The event "bright red spots appeared next day, first on left forearm, now appearing on right forearm/ few pin pricks of red appear on left arm" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of erythema.  Additional information: Several weeks after the second dose, she noticed blood spots, bright red, under the skin of  left forearm. Also, appearing on right forearm, but mostly on left ( also contracted a mild case of shingles on left upper thigh/buttock several months after second dose. The blood spots persisted, appearing plus disappearing consistently until 6 months after second dose. She thought they were gone and after booster, they appeared immediately the next day on right arm and continue to present mostly on right arm, sometime quite large; at times a few pin pricks of red appear on left arm. They do not itch, burn or hurt. However, I never had such spots prior to vaccination and  wonder what is causing them and why.  No follow-up attempts are possible. No further information is expected.