chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a female who on 04-JUN-2007 was vaccinated with a first dose of GARDASIL. The patient received a second and a third dose of GARDASIL on 31-JUL-2007 and 28-DEC-2008 respectively. The patient had an abnormal pap and was positive for HPV. The patient had normal pap tests in 2006, 2007 and 2008. At the time of this report the patient had not recovered. Follow-up information was received from a physician via medical records. It was reported that the patient is a 21 year old female student. On 04-JUN-2007, the patient was vaccinated with a first dose of GARDASIL (lot# 657621/0387U) IM into her left deltoid. The patient received the second and a third doses of GARDASIL on 31-JUL-2007 (IM into her left deltoid, lot# 658094/0524U) and on 28-DEC-2008 (IM into her left deltoid, lot# 658488/0930U) respectively. On 03-AUG-2009, a PAP test was performed and revealed atypical squamous cells of undetermined significance. Bacteria (coccobacilli) was also present morphologically consistent with shift in vaginal flora, which was a bacterial vaginosis. The patient was positive for high risk HPV. No further information is available.
Upon reviewing drawn up doses remaining for Moderna vaccine it was noticed we had one extra dose than we should based on appointments for the day. Determined one of two patients must have received Pfizer instead of Moderna booster. After administering doses it is unknown which of two patients received erroneous dose.
PATIENT COUDN'T WALK SINCE 23RD, 12DAYS AFTER RECEIVING VACCINE. LEFT LEG SWEELLED UP. HUSBAND TOOK HER TO EMERGENCY DR'S DID FULL STROKE PROTOCOL. PATIENT IS STILL IN ICU.
Loss smell; Loss of taste; Swelling on the injection site; Purple red circle on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss smell), AGEUSIA (Loss of taste), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE ERYTHEMA (Purple red circle on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported. No relevant concomitant medications reported.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss smell), AGEUSIA (Loss of taste), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE ERYTHEMA (Purple red circle on the injection site). At the time of the report, ANOSMIA (Loss smell) and AGEUSIA (Loss of taste) had not resolved and VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE ERYTHEMA (Purple red circle on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on 01-MAY-2021 included events outcome not resolved On 25-May-2021: Follow up received on 01-MAY-2021 contain significant information that outcome of events not resolved still after 3 month. On 02-Jun-2021: Email from reporter, still waiting on answer. On 02-Jun-2021: Email On 02-Jun-2021: Follow-up case booked in ,routed for triage
Extrem hair loss which continued for almost 6 weeks. Most of my hair is gone and I have bald spots on my head.
This spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M031574 with an expiration date 11-NOV-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of RECOMBIVAX HB experienced the temperature excursion of 1 degree Celsius for 93 hours. A digital data logger was involved. There was no previous temperature excursion. This is one of several repots received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013107: US-009507513-1703USA013108: US-009507513-1703USA012989.
Angioedema developed about 26 hours after her injection. Started with left upper lip, progressed to both lips by about 8 hours later.  She had taken 2 benadryl but did not seem to improve trajectory of swelling. The whole episode lasted about 17 hours. No other systemic symptoms.   Patient also has an alpha gal allergy. No known ingestion of red meat however that day. There is a small risk cross contamination for the lunch she had that day but seems less likely as well.
Patient had no symptoms, but tested positive for COVID-19 during response testing for an outbreak in a homeless shelter.
Subsequent to receiving third dose of Lymerix, the pt experienced generalized muscle aches. As of 09/10/2000 the outcome of the event is ongoing.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
INADVERTENT ADMINISTRATION OF JANSSEN COVID-19 VACCINE THAT WAS BEYOND THE BEYOND USE DATE; This spontaneous report received from a pharmacist concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, gastroparesis, and hepatosteatosis, and other pre-existing medical conditions included: No known drug allergies. Patient was on medications (not listed). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-AUG-2021, the patient experienced inadvertent administration of janssen covid-19 vaccine that was beyond the beyond use date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inadvertent administration of janssen covid-19 vaccine that was beyond the beyond use date was not reported. This report was non-serious.
Received IMOVAX Rabies post exposure treatment in response to the vaccine recall from Aventis Pasteur.  Received RIG and 5 doses of IMOVAX.  On first injection of IMOVAX c/o soreness at injection site that was not inconsistant with normal side effects of receiving an injection. Each additional injection stated had soreness as one would have upon receiving an injection.  Last injection given 5/18/2004.  C/O intermittent sorness after that date until on 6/8/2004 C/O of continuos severe pain (states kept her awake at night)at injection site of the IMOVAX. S/S were: pain, swelling at the site. no redness noted.  Seen by physician on 8/10/2004.  Reported that doctor noted swelling at the injection site, tightness in the deltoid and biceps muscle of her right arm, palpated a concentrated lump at the injection site and client was unable to lift her arm out to her right side. No redness or heat noted, temperature normal. Did not think there was evidence of infection.Recommended treatment of ice pack and ADVIL times one (1) week then to return for another evaluation if still in pain. As of this date (6/16/2004) client states her arm is not as painful but there is still swelling and pain and is experiencing still some immobility.
A third dose of monovalent Pfizer Orange Cap 5-11 years old was administered instead of a bivalent booster dose.
One Friday Pt had low-grade temperature after imms and was given Infant Tylenol. Pt stayed Friday with Aunt and was picked up by father on Sat evening. Pt had low grade temperature until approx 11:00 Sat night with 103.3 gave more Tylenol at 11:30. Temp increased to 104.4 and was taken to ER at hospital. Blood and urine tested, chest x-ray. Was told by ER doctor to give Tylenol and Motrin and see FMD on Tuesday.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient with drug hypersensitivity to penicillin. There was no pertinent medical history for the patient. On 30-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot number reported as: L003215 and expiration date: 30-APR-2016). No concomitant therapies were reported. Following vaccination the patient developed a blister at the injection site (injection site vesicles), which bursts open the next day on 31-MAY-2015. The patient contacted his pharmacist in regards to the event, however no treatment was given. The outcome of injection site vesicles was unknown at the time of this report. The reporter did not provide a causality assessment for the event. Additional information has been requested.
I took a Benadryl one hour after my shot - because I felt my throat was getting a little itchy. And I do get anxiety. The first side affect - my arm got super sore. That lasted 24 hours. The second day, about 26 hours later (from vaccine) - I got a mild backache. Mild headache, too, which I actually got 7 days after the vaccine. Five days after the vaccine, GI upset - diarrhea - it lasted five days. I talked to my doctor about it - my doctor told me to stay hydrated.
erythema 10x10 cm surrounding inject site with pain, redness x 8mm
Cellulitis of skin at injection site, pain, redness, swelling.  Treated with Keflex and Benadryl.
09/14/22, injection site arm was sore.  I was fatigued the next day and arm was more sore.  On Friday, I was less fatigued.  On Sunday, I had under my armpit across my ribs, an inflamed, red, itching patch. I went to the doctor on Monday and she diagnosed me with Shingles. She asked me to see an allergist on Tuesday, who agreed it was Shingles.
This spontaneous report was received from a 27 year old female patient concerning on herself. The patient had no medical history, drug reaction or allergies. The patient's concurrent conditions and concomitant therapies were not reported. On 06-OCT-2017, the patient was vaccinated with the second dose of RECOMBIVAX HB by intramuscular route (strength, dose, lot number and expiration date were not reported) for prevention of infection caused by all known subtypes of hepatitis B virus. On approximately 10-OCT-2017 (reported as "4 days later"), the patient began to have tingling sensation in her right calf, which got progressively worse. In approximately 2017 (reported as "shortly after that"), the patient was unable to support her own weight on her right knee and almost fell over (joint instability). No treatment was given for the events. However she saw her physician who did some unspecified blood work and recommended that she saw a neurologist. The patient also stated that she did not have an appointment with the neurologist until January 2018. At the time of the report, the patient had not recovered from the events. The causality between the events and the RECOMBIVAX HB was not reported.
Administered a dose of Havrix on 19Jun2023 which expired on 25 May 2023; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 7-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   On 19-JUN-2023, the patient received the 2nd dose of Havrix. On 19-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Administered a dose of Havrix on 19Jun2023 which expired on 25 May 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that at the time of reporting, the dose was not repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
Information has been received from a licensed visiting nurse concerning a 22 year old female who on 09-MAR-2010 was vaccinated with the first dose of GARDASIL at 9:00 AM. On 09-MAR-2010, the patient experienced fever and shortness of breath at 18:00 PM. The patient sought unspecified medical attention. The reporter stated that the patient took TYLENOL and CLARITIN and then was fine. Additional information has been requested.
first dose in June of 2018; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient.  The age at vaccination was not applicable for this report. The patient stated after receiving 1st dose of Shingrix he was not told that he needed a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up. The patient did not provide any additional details.
I was given the second vaccine on 1/21/21, on 3/3/21 I was congested and stuffy. By Friday 3/5/21 I has sinus pressure, headache, fatigue, and very congested.
Day 1 sore arm at injection site Day 2 -4 am nauseous       6am vomiting every 30 min ... unable to keep anything down. 1/2 phenergan suppository used. Still vomiting x 2. Additional 1/2 phenergan given. No more vomiting.
Patient received BOOSTRIX at 4:30 pm 4-2-13 called HD 4-3-13 to report he developed itching and hives on Lt upper back 1-2 hrs after receiving the injection. He self treated with BENADRYL 25 mg 2 tabs and BENADRYL cream. Itching and hives resolved with 30 min. Subsequently pt. reported possibility of exposure to ant bite as he now remembers sitting in a chair with ants, but did not feel a bite at the time.
In preparation of medication administration I read the ordering physicians toddle note which stated these vaccines. The series was not per protocol as vaccine had different schedule date to delay. Orders were cross examined post administration. I told physician immediately + mom to pt.
On 12/10/2021 I had my Pfizer Booster. On 12/12/2021 I began spotting & on 12/13/2021 it was confirmed after heavy bleeding and an ultra sound that I had a complete miscarriage.
itchy full body hives; 102 degree fever; minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache); minorly ill (general body soreness/fatigue/headache)/low grade headache; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 12Jul2021 (at the age of 24-year-old) as single dose for COVID-19 immunisation. Medical history included season allergies for pollen. Concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. The patient previously received 1st single dose in left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jun2021 (at the age of 24-year-old) for COVID-19 immunisation. Patient felt minorly ill (general body soreness/fatigue/headache) on Tuesday 13Jul2021 and felt better on Wed (14Jul2021) during the day with low grade headache as main symptom. Wed night, patient had a 102 degree fever which dissipated by noon on Thurs. Thursday night (15Jul2021 20:00), patient developed itchy full body hives which still had currently. Patent was taking diphenhydramine hydrochloride (BENADRYL) and prescribed prednisone steroid to prevent itchiness. Essentially stayed in bed the majority of the week and ate very basic meals - not aware of anything that would have triggered these hives and have never had hives before. AE resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. The outcome of the event Hives was not recovered, of the event Fever was recovered on 15Jul2021, of other events was recovering.  Information about Lot/Batch number have been requested.
Mild headache congestion; frog in my throat coughing and tiredness lasted for two weeks.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WHEEZING (Wheezing), BRONCHOSPASM (Had Broncospasms) and DYSPNOEA (Couldn't Control Breathing) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (did not have previous diagnosis of covid-19.).   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion hospitalization), BRONCHOSPASM (Had Broncospasms) (seriousness criterion hospitalization) and DYSPNOEA (Couldn't Control Breathing) (seriousness criterion hospitalization). The patient was hospitalized from 19-Apr-2021 to 19-Apr-2021 due to BRONCHOSPASM, DYSPNOEA and WHEEZING. At the time of the report, WHEEZING (Wheezing), BRONCHOSPASM (Had Broncospasms) and DYSPNOEA (Couldn't Control Breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not experience any events with 1st dose of the vaccine. Patient was treated with albuterol. He was discharged 3 hours later and given prednisone and albuterol. He was advised to take prednisone if required. 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. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Additional document received on 20 Apr 2021 included seriousness criteria updated to serious; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Next day post vax, the pt's left arm was swollen. Mother brought child to ER. Physician gave a pink medicine. Arm is still swollen from shoulder to elbow per mother.
Moderate/Severe swelling and redness at site. Extends to approximately 4 inch circular diameter surrounding injection site.  Painful when using. Tightness of skin.
low grade temp-high temp & sz;glands in neck & back of head swollen;rash over entire body;
Swollen, redness and itching. Patient took Benadryl and put ice on.
Red swollen, left arm, edema, induration, pain at site (5cmx5cm).
Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pneumonia without fever was made, patient started azithromycin on 1/5 and albuterol treatments every 4-6 hrs. Initially he improved, but then worsened.  chest xray on 1/6 was negative for pneumonia, PCR covid test was negative, albuterol treatment did not bring much relief. He started respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered thrombolysis and was discharged home from the ICU on 1/12 on oral anticoagulants. He is gradually improving, but very weak. He tires easily and gets a drop in oxygen to 90- 93%, as well as an increase in the heart rate to 120  when walking less than half a mile. He runs out of breath with exertion.
Severe shoulder pain. I had a burning sensation in my shoulder immediately following the vaccination which lasted about an hour; I received my vaccine Friday afternoon. I woke up Sunday morning with a terrible pain in my shoulder, the same place that had previously experienced the burning sensation. It is painful to raise my arm or rotate my shoulder. Even deep breathing/yawning causes pain in my shoulder. I have tried taking over the counter ibuprofen and Aleve and it has not helped. I have also had a headache since Saturday.
Hives upper torso (within 8 hours of shot) Orange urine and less urination (within 12 hours of shot) Swelling of joints and exhaustion (within 3 hours of shot) Nausea- loss of appetite (within 3 hours of shot)
Real tired within 1 hour.  Nap, up at 2:30pm. 7/25/06 upset stomach.  Irritated with being outside in sun, "too bright".  Real tired til noon.  7/26/06 left deltoid hard, warm to touch, redness 25 mm x 4.5 mm.
Initial report received on 17 June 2014 from an investigator participating in a trial. A 24-year-old male subject, with no relevant medical history, had received an injection of ACAM2000 on 03 May 2011 (lot number, route and site of administration were not reported). On 09 June 2014, he presented with elevated troponin with a mild severity. No cardiac symptoms have been identified. He had a normal ECG. Troponin test was repeated 2 days later and yielded same results. No further information is expected to follow. No corrective treatment was received. At the time of the report, the patient was not recovered. The investigator reported that a cardiac etiology is unlikely, but subject was referred appropriately. Relationship was assessed as remote. List of documents held by sender: none.
After vaccine was administered, 4:40 pm, I was feeling my heart palpitating fast like an anxiety attack. I also experienced a headache, fatigue, body ache and arm pain that same day at 4:58 pm, and around 6:15 pm I my whole body was itchy. The next day January 12, 2021, I woke up with a fever of 100.2, still with body ache, headache, but no longer body itchiness. Yesterday January 14, 2021 and today January 15, 2021 still having headache, body ache pain did decrease.
Nausea and slight temperature; left arm was so painful that client could not lift it.  Pain continued for 2.5 days.
Day 7: Itchiness Day 9: Itchiness, redness, and swelling
Patient received undiluted dose of smaller dose Pfizer.  No reported side effects 7:00pm  12/16/2021