chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours after the shot my daughter became extremely weak and sore; 24 hours after the shot my daughter became extremely weak and sore; High fever of 103.4; Lots of congestion; Cough; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 11-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Dec2021 at 16:00 (Lot number: FL0007) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There was no concomitant medication. The following information was reported: ASTHENIA (non-serious) with onset 04Dec2021 at 17:00, outcome "not recovered", described as "24 hours after the shot my daughter became extremely weak and sore"; PAIN (non-serious) with onset 04Dec2021 at 17:00, outcome "not recovered", described as "24 hours after the shot my daughter became extremely weak and sore"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "High fever of 103.4"; NASAL CONGESTION (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Lots of congestion"; COUGH (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Cough". The events "Extremely weak", "Sore", "High fever of 103.4", "Lots of congestion" and "Cough" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown whether therapeutic measures were taken as a result of the events asthenia, pain, pyrexia, nasal congestion and cough.  Additional Information: It was reported that around midnight she developed a high fever and they had been battling it all night. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 06-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 29-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
after receiving first dose of Shingrix on Wednesday to her left deltoid. The following day despite taking OTC Tylenol and Ibuprofen for pain experienced a temp of 102.3 requiring that she left work. Reports improvement in localized erythema and warmth. Yesterday she noted a macular pinpoint rash to anterior left upper arm medically without associated pain, itching, warmth.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  Pharmacist reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022  This case contains information for the 7th of 20 adult patients described by the reporter.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662861, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663010, US-MODERNATX, INC.-MOD-2022-663011 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849:Patient 1 US-MODERNATX, INC.-MOD-2022-662859:Patient 2 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662861:Patient 4 US-MODERNATX, INC.-MOD-2022-662863:Patient 5 US-MODERNATX, INC.-MOD-2022-662865:Patient 6 US-MODERNATX, INC.-MOD-2022-662869:Patient 8 US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662873:Patient 10 US-MODERNATX, INC.-MOD-2022-662875:Patient 11 US-MODERNATX, INC.-MOD-2022-662876:Patient 12 US-MODERNATX, INC.-MOD-2022-662879:Patient 13 US-MODERNATX, INC.-MOD-2022-662881:Patient 14 US-MODERNATX, INC.-MOD-2022-662958:Patient 15 US-MODERNATX, INC.-MOD-2022-662995:Patient 15 US-MODERNATX, INC.-MOD-2022-663010:Patient 16 US-MODERNATX, INC.-MOD-2022-663011:Patient 17
Site redness, hardness, swelling; warm to the touch; swelling/hardness approximately 3.5" wide, 2" tall, at the side of injection
diarrhea x 15 days (started the evening of injection and continues now) Red raised rash at injection site that appeared 13 days after injection. Slightly warm, tender to the touch and somewhat itchy.
The patient was very nervous before the injection. Approximately 5 minutes post-injection, the patient felt very anxious and reported feeling cold. Her parents had her lay on the floor. I held an ammonia inhalant close to her. She was breathing normally, but visibly nervous. I asked about her medical history and parents reported a history of seizures.  They said she normally experiences flashing lights before a seizure; but she did not report a prodrome. I called for an ambulance for her to be assessed. The parents asked for her to be hospitalized for a workup.
Rash - Was given Shingrix vaccination 9/5/19. Rash began next day at injection site in L deltoid. Red, itching, burning, warm. Triage nursing advised Tylenol and Benadryl, appt scheduled to be seen in clinic today - When injection was going in felt pain, stinging different than a shot. Could feel the medicine going into her system. Sat for 10 minutes after injection, felt tightness in chest and in head like pressure. Vaccine placed around 5:15, Tired, left pharmacy around 6pm. Pressure in chest and head resolved within a few hours and has not returned since - On 9/6 first noticed rash, started feeling warm in the arm around injection site, red and itchy. Burning, unpleasant. - Since noticing it the burning and itching comes and goes. Rash seemes to be receeding. - Has not taken any medicine or used any cream
Patient received 0.2mL of the COVID19 Pfizer-BioNTech vaccine which was not diluted per recommendations for the pediatric dose (5-11)
Vaccinator noticed increased bleeding after injection and beginning of small area of blueish swelling approximately 2cm in diameter at the injection site.  Pressure was applied by vaccinator and bleeding was quickly controlled.  Injection site began bleeding minimally again during 15 min. observation period and pressure and ice  were briefly applied until bleeding was controlled again.  No other complaints of pain or reactions to vaccine apparent.  Patient remains at site as he is working at the site as a county employee.
This is a spontaneous report from a contactable physician. This physician reported similar events for 4 patients. This is the 1st of 4 reports. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumococcal infection and hemolytic uremic syndrome on an unspecified date with outcome of unknown. The information on the lot number has been requested. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine towards the occurrence of pneumococcal infection in this patient cannot be completely excluded. Hemolytic uremic syndrome might represent the complication resulting from  pneumococcal infection. 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-2018410910 Same reporter/drug/event, different patient; US-PFIZER INC-2018410911 Same reporter/drug/event, different patient; US-PFIZER INC-2018410912 Same reporter/drug/event, different patient.
"covid arm"  Itchy deltoid region on arm of injection with palpable bump beginning about 7-8 days after vaccine, progressing to large oval round itchy patch at test site.  Pt reports also mild fatigue and achiness that is easily managed at home.  Was diagnosed w/ COVID on 2/2/2021, tested d/t recent exposure.
Throw up every 2 hours. Got very dehydrated. Very bad equilibrium. Could not stand for more than 5 minutes before getting very weak and had to lay down. Bed rest for 2 days.
Both shots made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR128862   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient was sick after the shot. The patient heard shingles was a lot worse. The follow-up could not be possible as no contact details were available. Additional supportive information: The case had been linked with US2022AMR128862  reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR128862:Same reporter.
Initial information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2019SA055109 and 2019SA056156 (same reporter). This case involves a 60 years old male patient who received a 0.5ml single dose of vaccine FLUZONE QUADRIVALENT prefilled syringes batch number: LB549 (expiry date: 30-Jun-2019) via intramuscular route in left deltoid on 11-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications was taken. It was an actual medication error due to incorrect product storage. FLUZONE QUADRIVALENT had temperature excursion which had already been used on 3 separate patients. The nurse stated that they did not catch the temperature excursion because the data logger did not alert as it was supposed to. It was reported that no adverse event was observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
(L) arm had red, raised area and (R) arm had a smaller red area, but upper arm was more swollen. Pt used TYLENOL and cool compresses with good relief.
Swelling in upper thigh, itching and redness. Treatment Oral Steroids Tapering(Over 11 Days) 2 2x Day for 5 days, 1 2x Day for 3 days, then 1 Per Day for 3 days.
Left shoulder swelling, painful and redness. Ice compression every 30 minutes at least 2-3 times a day.
On 7/16/16 patient went to Urgent Care for rash at injection site, diagnosed as cellulitis. Treated with antibiotics. Followed up 7/26/16. Rash cleared.
Headache; Left Eye is Jumping; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 (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 (1st DOSE), administration date: 14May2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 22Jun2021, outcome "not recovered", described as "Headache"; MUSCLE TWITCHING (non-serious) with onset 22Jun2021, outcome "unknown", described as "Left Eye is Jumping".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine EUA  Friday morning after receiving the shot I could not stand up straight I was so achy I had a headache and was nauseous. I did dry heave over the toilet several times in the morning. Saturday my symptoms subsided. I wasn't as achy and could stand up straight. I was nauseous and had a headache. By Sunday I was only nauseous.
4 hours of chills, fever, aches, 16 hours sluggishness, 1 episode of diarrhea .  Then completely fine
Patient / is past due for dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th December 2019, batch number 29RD5, expiration date 16th April 2022).   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 age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, the patient was past due for dose 2. The reporter consented to follow up.
Systemic: Tinnitus-Medium, Additional Details: Intermittent tinnitus since a few days after administration
Pt was inadvertently given Pfizer Covid 19 vaccine for a second dose instead of Moderna Covid 19 Vaccine.
This is a spontaneous report from a contactable pharmacist received via the non-clinical study program for healthcare providers. A 65-year-old female patient of unspecified ethnicity started to receive PREVNAR, single dose via an unspecified route of administration on 04FEB2015. Relevant medical history and concomitant medications were not reported. The patient experienced little soreness, felt little hard in the injection site area and tenderness in the area where it was administered on an unspecified date with outcome of unknown. The pharmacist was not sure if the events were due to PREVNAR or not.
No adverse event; Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccine 4 weeks prior to COVID-19 vaccine.     On 28-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Booster of Moderna COVID-19 vaccine).    Dosage text for suspect product was reported as additional booster.  Concomitant drugs were not reported.  It was reported that the individual adult bivalent vial of 2.5 ml size was not exposed to temperature excursion. It was unknown when the vial was initially stored in refrigerator.  Treatment medications were not provided.  This case was reported for adult patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-717526 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717526:Patient 1 out of 2 adult patients
Information has been received from a licensed visiting nurse concerning a patient who on 21-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658374/1117U) who experienced redness and induration at the injection site following vaccination. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information not expected.
On day 11 I started to get hives on neck. They progressively got worse over the next two days. I went to urgent care and was prescribed pretisone and another antihistamine. I?m also taking Zyrtec and Benadryl. I am on day 5 of the steroids and still have hives.
11/12/2021- I started feeling ill-  sinus infection and general  respiratory infection. I took a rapid COVID-19  test at home- it was negative. I took Mucinex.   On Saturday,  11/13/2021 I had post nasal drip,  throat was hurting, fever and chills.  On Sunday, 11/14/2021 - Urgent Care, I took a joint - COVID-19 test and flu test and it determined I was negative. They gave me cough syrup and told me to stay at home and contact my general doctor if it got worse.  My primary care doctor said to continue taking Mucinex, and Flonase if I was not getting better in 48 hours to come back.  I don't feel 100 % but I am better than I was 2 days ago. 11/16/2021-  I have not fully recovered but I am almost there.
Client received dose 1 of Janssen Covid 19 vaccination at 1207. Client lost consciousness at 1208. Client lowered to floor by staff nurse. Client laid on the floor with feet elevated for 12 minutes. Client sat up and completed 12 oz of water and a bag of crackers. V/S WNL client noted A x O x's 4 with no further complaints noted. Client sat outside in the monitoring area for an additional 15 minutes post sitting up inside of the building, verbalizing his person, place and his current situation.   Initial v/s 109/61, O2 100% on RA and HR 82.  Client discharged by MD.
had a severe pain in upper left hip; hurt to lift my left leg up (while taking a step forward); This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscular in the left arm on 24Dec2020 08:15AM at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included lyme disease from 2014. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive other vaccines in last four weeks. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 25Dec2020 07:30AM, the patient had a severe pain in upper left hip. It felt like an IT band issue she had before but this time it didn't radiate to her knee like it usually does. She did not have exercise since the morning of the 22nd when she did an upper body weight-lifting session. She took ibuprofen that took the edge off, and she was able to finish her day as a nurse in the Covid ICU. The following morning, she felt fine and went to her other job. She was fine in the morning during her usual drills practicing getting out of the helicopter while on the ground. She sat in one of the seats for about 15 minutes while having a discussion when she started to feel the pain again. She got out of the helicopter and tried to walk around, but it hurt to lift her left leg up (while taking a step forward) in Dec2020. She has never experienced this before. She limped back to the hanger, took ibuprofen 600mg and rested/stretched for an hour. The pain was reduced to a minor and tolerable ache. The outcome of the events was recovering. The report was considered non-serious.
AFTER 2 HOURS OF RECEIVING THE VACCINE PATIENT DEVELOPED DIARRHEA.
pt recv vax ID inadvertently & devel localized itching;on 23aug94 MD reported pt has recovered;