chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Miscarriage; This is a spontaneous report from a contactable other healthcare professional (patient).  A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Sep2021 (Batch/Lot Number: FC3184) (at the age of 35-years-old) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included sulfa allergy, polycystic ovarian syndrome (PCOS), pseudotumor cerebri, and depression; from unknown dates and unknown if ongoing. Patient was pregnant at time of vaccination, date of LMP was on 12Jun2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included duloxetine hydrochloride (CYMBALTA); folic acid; ascorbic acid, biotin, calcium pantothenate, camellia sinensis leaf, carotenoids nos, choline bitartrate, chromium picolinate, colecalciferol, copper citrate, ferrous fumarate, folic acid, inositol, magnesium glycinate, magnesium oxide, manganese citrate, mecobalamin, molybdenum aspartate, nicotinamide, phytomenadione, potassium bicarbonate, potassium iodide, punica granatum fruit, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, thiamine hydrochloride, tocopheryl acid succinate, zinc glycinate (BARIATRIC ADVANTAGE ULTRA MULTI WITH IRON); lorazepam (ATIVAN); and galcanezumab (EMGALITY [GALCANEZUMAB]); all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Aug2021 (Batch/Lot Number: FA7485) (at the age of 35-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 01Oct2021, the patient experienced miscarriage (medically significant).The mother was 16 Weeks pregnant at the onset of the event. The mother was due to deliver on an unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative  in Sep2021, negative on 25Oct2021.  The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of miscarriage which included dilation and curettage (D&C). The outcome of the event was recovered with sequelae.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events miscarriage. The case will be reassessed once new information is 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
Next day in the evening started developing pain in spot of injection, headache, body aches, fever.  On day 4 diarreah and stomach aches started that have persisted till now, currently has been 1 week since 1st dose
Full body skin rash with intense itching. Went to doctor on 8-4-14 and received steroid injection.
arm is extremely sore- below injection site is very red, swollen, and hot to the touch. It looks like a giant welt, it has grown in size each day
Chills, Fever of 101.6 , exhaustion could not get our of bed, very bad headache
2 days p/vax hands swelled, white, hives, itching;4 days later hands & feet hives;no illness, no change eating/detergent, etc;only poss thought was hep vax;went to ER-MD;
Breakthrough case after four vaccines  Pfizer 2/3/21 Lot# EL9265;  2/23/21 Pfizer Lot# EN6200;  Pfizer 11/15/21 Lot# FF2590;  Pfizer 9/1/22 Lot# FP7139
Around 15 minutes after receiving vaccine, patient started to stare off into space(blank stare). He was sweating, pulse was very weak, and he started to drool at the mouth. Wife kept stating that he did this at home sometimes and it was not related to the shot. Epi was administered and ambulance was called. Before ambulance arrived, patient started to respond to wife and HD personnel. EMT's evaluated him and wife did not want him to go to the hospital. EMT's agreed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), at the age of 78 years in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Paxlovid was administered from 06Apr2023 to 10Apr2023 as therapeutic measure as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 to the events COVID-19 and drug ineffective cannot be ruled out.
3 Hours of Chills, 5 days of nausea, 12hrs of vomiting, 3-4 days fever, low energy.  Minimal arm pain at injection site, but random shooting pain at injection site very infrequently.
2nd day:  Soreness of injection site 3rd day:  Soreness  of injection site with swelling  at site 4th day:  Soreness with sensitivity to touch throughout the upper part of the arm 5th day: Severe pain throughout the arm. Numbness in my fingers.  light headiness, passed out for a few second.  light tremors.
Left arm/shoulder stiffness, bruise at site of injection, red, hot, skin down to elbow and part of chest on left side. Pain.
knuckle pain in left hand; Rheumatoid arthritis flare up; feeling bad; Limbs stiffness/left hand stiff; This is a Solicited report from a contactable consumer (patient) based on the information received by Pfizer from Regulatory Authority (Manufacturer Control No: 21K-163-4111174-00).   A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 and dose 2; both intramuscularly in 2021 as single dose for covid-19 immunisation; upadacitinib (RINVOQ), from an unspecified date to 2021, then from 2021 to 2021; both orally at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up, feeling bad, and limbs stiffness in 2021, knuckle pain in left hand on an unspecified date. The case was serious per medically significant. Events details: Four months ago in Jun2021, the patient had a knuckle replacement surgery in left hand due to knuckle pain. The physician had advised her to stop upadacitinib for a week in order to evaluate how she did without upadacitinib. It was horrible after three days with her left hand stiff, but she no longer had the pain. She had a terrible feeling with rheumatoid arthritis flare ups with every single symptom after receiving the covid vaccine. She had stopped upadacitinib two days prior to the second injection. The action taken in response to the events for upadacitinib was unknown. The outcome of event knucle pain in left hand was resolved, outcome of other events was unknown.  Causality for upadacitinib: The reporter's causality for the event of knuckle pain in left hand with upadacitinib was a reasonable possibility. The reporter's causality for the events of feeling bad, limbs stiffness and rheumatoid arthritis flare up was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of knuckle pain in left hand, feeling bad, limbs stiffness  and rheumatoid arthritis flare up are related to upadacitinib.  The reporter's assessment of the causal relationship of the events with the suspect product 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 the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of knuckle pain in left hand, feeling bad, limbs stiffness  and rheumatoid arthritis flare up.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
Stiff neck; Swollen right arm lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and LYMPHADENOPATHY (Swollen right arm lymph nodes) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) and LYMPHADENOPATHY (Swollen right arm lymph nodes). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) and LYMPHADENOPATHY (Swollen right arm lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment medications were reported.
Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXD34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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-AUG-2022 Reporter's comment: The nurse reported that a patient received a ten days expired dose of Bexsero. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Bexsero, which led to expired vaccine used.
PREVNAR in right arm, had large "bubble", went away after 36 hours, bruise developed, developed rash on thigh above knee unilaterally, went away. Has developed night sweats then night sweats dissipated, lost wt (13 lbs).
The 1st dose of Moderna vaccination, I was experciencing flu like symptoms and had swelling (edema) in the left arm for about 3 to 4 days where the injection was administered. The 2nd dose of the Moderna, I had flu like symptoms again andthe  symptoms lasted for about 2 days.  Six days after the Moderna vaccine,  I noticed swelling  (fluid / edema ) on chest, breast, neck , upper back on the left side and immediately saw my Endocrinologist. We acknowledged that it was an adverse reaction to the vaccine. The swelling dissipated after 3 days taking Advil and Zyrtec.
48 hours. Body aches. Dizziness. Nauseous . Swollen glands.
felt drugged-out; it feels like she is coming down with flu; sore throat; joint aches; headache/severe headaches; chills; body aches/more body aches; feeling tired/tired/extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced FATIGUE (feeling tired/tired/extremely fatigued). On 09-Aug-2021, the patient experienced MYALGIA (body aches/more body aches). On 10-Aug-2021, the patient experienced CHILLS (chills). On 11-Aug-2021, the patient experienced HEADACHE (headache/severe headaches). On an unknown date, the patient experienced EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat) and ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 13-Aug-2021, CHILLS (chills), MYALGIA (body aches/more body aches) and FATIGUE (feeling tired/tired/extremely fatigued) had resolved. At the time of the report, EUPHORIC MOOD (felt drugged-out), INFLUENZA LIKE ILLNESS (it feels like she is coming down with flu), OROPHARYNGEAL PAIN (sore throat), ARTHRALGIA (joint aches) and HEADACHE (headache/severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  On 09-Aug-2021, the patient felt extremely fatigued and tired. On 10-Aug-2021, the patient had more body aches. The patient received her vaccination in her right arm shoulder deltoid muscle.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: New reporter demographic details; date of birth of the patient; vaccination date, route and anatomical location; corrective treatment and new events were added.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No information was reported on date of the storage of vaccine in refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.- Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Fever to 100 with severe body Acheson fatigue on 4/25/21. On 4/26/21, MS flare symptoms with vertigo/dizziness began, with worse balance, fatigue,  cognitive issues.
I received the second Shingrix vaccine on 3/15/23 in my left deltoid. The following day I had redness the size of the palm of my hand under my deltoid. There was also extreme tenderness. The redness continued for 3-4 days. On the 3rd day I started to also experience itching in this area. I used Benadryl ointment on the area and took Advil. Everything was resolved on day 5.
Pfizer 6/25/21, 7/23/21. Positive on 11/14/22
I was about 28 weeks pregnant when I got the Moderna COVID19 vaccine. This is my first pregnancy. My due date is 03/28/2021.  About 10 hours after receiving the vaccine I noticed a round, 2-inch diameter spot on my arm about an inch away from the injection site. The spot was red, warm, swollen, and painful to the touch.  My arm began hurting that night and hurt for a few days then the pain and the spot went away.  Then, about 10 days later I noticed the red, swollen, warm spot had returned in the same place it was 10 days prior. The only difference was that upon it's return it did not hurt to the touch, but the color, swelling, and warmth was the same.  I didn't ice the spot when it first appeared or when it appeared a second time. I haven't treated it in any way and have yet to inform my physician. I do want to know if it is safe for me to take the second dose of the vaccine--I'm scheduled to take it on 02/04/2021.  I had an ultrasound appointment yesterday, 1/18/2021, and the technician told me the baby's current weight is 3 lbs. 8 oz., which is what would be expected at this stage (30 weeks, 1 day).
Patient was given Varicella vaccine on 11/15/2022 not knowing the patient had received another live vaccine-MMR on 11/03/2022 in another facility which invalidated her Varicella vaccine. No reaction was reported.
I got flu like symptoms for three days and now I have nausea and pain in my kidney area.
Received the second vaccine yesterday 1/27/2021 around 11am. About an hour later started to get hives and took a Claritin. Was at home later in the evening around 5pm and started to have lip/jaw swelling and throat tightening. Called an ambulance and they gave her EPI pen and took over treatment. Ended up getting discharged around 11-12pm last night and told to take prednisone and Benadryl. Around 5am today 1/28 had swelling in tongue and bottom lip swelling. Went back to emergency room and they did similar treatment. Is planning to follow up with her doctor and will be on her prescribed medications for a few days.
Fever, fatigue chills started 2 days after 2nd Moderna shot. Menstral period was extremely irregular for 3 months after injection. About 5 months after injection noticed swelling in my neck. 3/2022 diagnosed with rare stage 3 salivary gland cancer.
Pt said shoulder where shot given hurt immensely, was sore and she could hardly lift it over her shoulder, after 2 weeks.
Throat closing, severe headache, low grade fever, muscles and joint aches, chest pains, and stomachache
Information has been received from a physician concerning a 5 year old male  who on 07/19/2000 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 03/09/2005 the pt developed a case of breakthrough characterized by 10-15 pox on his arms, torso, and face after being exposed at school. The pt was noted to be afebrile and had no itching. Unspecified medical attention was sought but no tx was required. At the time of this report, the pt was recovering. Additional information has been requested.
Extremely heavy period day 2 post-covid vaccination.  Was soaking through an ultra tampon every 45 minutes to an hour for about 30 hours. Was the worst period of my life. Heavy clotting & extreme cramping, which I do not generally ever get during my period. This was intense. It interfered with daily activities. Never experienced anything like this before. Was not normal for me. I was mid-cycle when I received the vaccine. This event was extreme, which is why I?m reporting it.
This spontaneous consumer report (initial receipt 12-Oct-2012) concerns a 69-year-old female patient, who had no pertinent medical history or taking any concomitant medication. She was allergic to penicillin, codeine and a few unspecified antibiotics. On 08-Oct-2012, the patient received AFLURIA (batch number was not provided) injection as flu shot. On 08-Oct-2012 the patient's lips swelled up and she had a rash that was itching on her arms and back. The next morning she was congested, nose was running and it felt swollen in her nose. No lab diagnostic study was performed. The patient sought medical attention by visiting to physician office and phone call to the pharmacy. The patient did not received any treatment for the events. At the time of reporting the patient's lips were still swollen but recovering.
Mid May my sinus was clogged that lasted for 2 months. Diagnosed ear infection and was put on AUGMENTIN. Had sharp pain in abdomen, went to ER and x-ray showed kidney stone.
3/4/2021  The call center received a call regarding a patient who had possibly received two doses of vaccine.  She had received her first dose of Pfizer in the morning on 3/4/2021.  The patient was called at 1730 to discuss what happened.  She states that that her vaccinator, LPN inserted a needle into her arm.  RN at that time realized that no vaccine had been drawn up.  She discussed with the patient that she would draw up a dose and administer it in the opposite arm. The patient states that she has a newborn at home and is very sleep deprived.  She wanted to make sure that if she had received two doses of vaccine, what the implications would be.  The patient spoke with both her OB and pediatrician whom she states do not have concerns at this time.  She states that on her left arm she does not have any soreness but on the right she "feels like she received a flu shot". Encouraged her to continue to monitor soreness and symptoms and write it down if she needed to and I would contact her the following day.  She verbalizes understanding and has no further questions.
Case number PHEH2014US003624 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 10-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 26 DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Localized pain and swelling with minimal erythema for approximately 1 week same day (7/2/13).
10 minutes after her immunization, Patient was standing next to her father. She had a glazed over look on her face, I asked her father to grab onto her. He eased her down to the ground and she lost conciousness for about 10 seconds. When she woke up, she was disoriented. Her father carried her to the bench where I checked her blood pressure. It was 76/31 p51. 2 minutes later it rose to 111/81 p 92. Pt was diaphoretic and clammy. Medical services came and she was monitored. Her BP stabilized and her blood glucose was 91. She refused transport to the hospital and left under the supervision of her parents.
pt recv vax 11NOV96 & immed exp severe pain @ inj site;pain persisted & was treated w/Flexeril;no inflammation present however area is still tender as of 14NOV96;