chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at the injection site; Initial information was received on 25-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via phone.  This case is linked to cases 2020SA218631, 2020SA219448 and 2020SA219456 (same reporter).  This case involves a 33-year-old female patient who experienced pain at the injection site (vaccination site pain), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant vaccine.   On 05-Aug-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (prefilled syringe, lot U6638AA and expiration date 12-Apr-2022) via an intramuscular route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed non-serious pain at the injection site (vaccination site pain), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, few weeks later the patient had recovered from the event.
21NOV93 muscular aches & pains, no fever, diarrhea & GI tract upset; took Vicodin 21NOV & felt better;
pt recvd vax;unconsolable crying;apap given q 4 hrs;
Fever for 12 hours (100.4 and higher), body and muscle aches, joint pain, headache  -tylenol and ibuprofen alternated every 4 hours
Overwhelming swelling and redness around injection site. Diameter of affect area is more than half of forearm. Increased firmness and tenderness. Mild chest pains.
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB, orally, lot number M014926, expiration date 17-FEB-2019, (dose was not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
2 mo male developed abdominal, frontal, back and extremity rash within 48' of injection. ROS (-) fever, not fussy, feeling normally.
"Worst experience of my life" I will never take this vaccine again, severe chills, rigors, chronic lingering cough for weeks.
Sharp pains in left breast first 3 days after shot  -  This has gone away Tingling in left arm and hand - day 3 - this has subsided Tingling and itchy feeling of face, head, feet and sometimes lower legs. - this continues Knotted feeling in middle of chest - sometimes feel short of breath, but doesn't get worse with exertion - this continues General fatigue  - first few days - this has subsided
Dose of Bexsero was given concomitantly with a dose of Trumenba on 05/16/2022; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number Abxc06AA, expiry date 31st March 2023) 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 16th May 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On 16th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 1 June 2022: Reporter's comment: Nurse reporting a dose of Bexsero was given concomitantly with a dose of Trumenba. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero and Trumenba concomitantly which led to overdose.
Fever 100; nauseous; joint pain mostly in legs; fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 59-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10Mar2021 at 15:30 pm (age at vaccination is 59 years) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any known allergies. Concomitant medications the patient received within 2 weeks of vaccination included irbesartan (AVAPRO), escitalopram oxalate (LEXAPRO), atorvastatin (LIPITOR [ATORVASTATIN]) and vitamin D [vitamin D NOS] all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11Mar2021 at 09:00 am, the patient experienced fever 100, nauseous, joint pain mostly in legs and fatigue. The patient underwent lab test which included body temperature: 100 (Fever) on 11Mar2021. No treatment was received for the adverse events. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Acute ataxia one day after receiving IPV 3rd dose & Hep B 3rd dose.Symptoms took 8-9 days to resolve.
Tongue is swollen; tongue very sensitive when eating with blisters around the edges; tongue very sensitive when eating with blisters around the edges; a swollen lower lip; Covid-arm rash at the site of the injection down to her elbow; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue is swollen), GLOSSODYNIA (tongue very sensitive when eating with blisters around the edges), BLISTER (tongue very sensitive when eating with blisters around the edges), LIP SWELLING (a swollen lower lip) and VACCINATION SITE RASH (Covid-arm rash at the site of the injection down to her elbow) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue is swollen), GLOSSODYNIA (tongue very sensitive when eating with blisters around the edges), BLISTER (tongue very sensitive when eating with blisters around the edges), LIP SWELLING (a swollen lower lip) and VACCINATION SITE RASH (Covid-arm rash at the site of the injection down to her elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Mar-2021 for Adverse event, at an unspecified dose and frequency. On 18-Mar-2021, VACCINATION SITE RASH (Covid-arm rash at the site of the injection down to her elbow) had resolved. On 28-Mar-2021, SWOLLEN TONGUE (Tongue is swollen), BLISTER (tongue very sensitive when eating with blisters around the edges) and LIP SWELLING (a swollen lower lip) had resolved. At the time of the report, GLOSSODYNIA (tongue very sensitive when eating with blisters around the edges) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   This case was linked to MOD-2021-120025 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Reporter details, patient demographics and event information updated
received Bexsero and Trumemba at same visit; flu like symptoms; sore arm; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date unknown) 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 and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 8th November 2021, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On 8th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. In November 2021, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of both Bexsero and Trumemba vaccines at same visit, which led to overdose. The patient experienced flu like symptoms and sore arm 24 hours after immunizations and lasted for 1 day. No further information reported. The reporter consented to follow up.
20-25 min post vaccine pt complains of dizziness, sweating. Patient laid down for approx 10 - 15 min and drank cola. BP taken was 160/120, which elevated but not abnormal. Pulse Rate - 67. After 10-15 min of sitting and cola dizziness improved as well as sweating. Pt. f/u @ 2pm. Feels "off". Not dizzy, but feels ok to work and drive.
p/vax pt devel constant crying & swelling @ site of inj;swelling persisted;
Beginning about 10 hours after the shot: headache, muscle aches, fatigue. Fever spiked at 101.5 about 30 hours after the shot, then declined over the course of the next 12 hours until it was back to normal.
Symptoms of Mini Stroke (TIA)  8 days following 2nd vaccine.  No previous history of blood clots.
Information was received on 07-JUL-2017 from a medical assistant who reported that a patient (demographics not provided) received only 2 doses of RECOMBIVAX (lot number and expiration dates unknown) on unknown dates, had titers drawn and was considered "immune". The primary reporter did not clarify if this patient was an adolescent when they received the 2 doses of RECOMBIVAX, which is why this is being reported. No additional information was available. This is one of two cases from the same reporter. Additional information has been requested.
started developing terrible pain; concerned about Lyme's diseases; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age reported for herself that she received second dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration as single dose for COVID-19 immunization. Medical history reported was ongoing rheumatoid arthritis. Concomitant medications reported was tofacitinib citrate (XELJANZ XR) for rheumatoid arthritis. Patient previously took first dose of bnt162b2 on an unspecified date for COVID-19 immunization. Xeljanz XR 11mg tablets, she was taking Xeljanz XR and was off of it for 3.5 weeks when got her covid shot, during that time she was in great pain because of the arthritis. Caller clarified she was Off of Xeljanz XR for a week, she had the covid shot, and then she stayed off Xeljanz XR for 1 more week and then went back on it. The Same thing happened with the second shot, she went off of Xeljanz XR for the second covid shot and was then only back on the Xeljanz XR for a short period of time because she started developing terrible pain, which she dealt with and took Advil to managed. Now with being told to go off the Xeljanz XR for 5 days, she has already started the Doxycycline and was said to go back on Xeljanz XR in 5 days. They added Zithromax 250mg once a day. Caller asked was that too much medication at one time. Caller explained that she was prescribed the Doxycycline and Zithromax because she was bitten by a tick, and so they are concerned about Lyme's diseases. Caller stated that she was practically in tick heaven. Outcome of the events was unknown.  No follow-up attempts possible. No further information expected. Information about Lot/batch number is requested.
Migraine; Body aches; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included generalised anxiety disorder and cystitis interstitial. The patient did not have a history of allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included oxybutynin hydrochloride (DITROPAN) and norethisterone acetate, ethinylestradiol, ferrous fumarate (BLISOVI 24 FE), both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the patient experienced migraine, body aches and hot flashes. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, body aches and hot flashes were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 22-JUN-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection, via intramuscular route, lot # M006922 with expiry date on 21-JUN-2017 (dose was not reported). No adverse effects were reported. Additional information has been requested.
Improperly handled vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Improperly handled vaccines) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Improperly handled vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Improperly handled vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The clinic reporter works at was administering vaccines today. Yesterday morning at 8:30AM an individual drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator. Today those vaccines were administered. They were removed from the refrigerator as needed for administration. All vaccines were administered between 1:00 and 3:30 PM. This patient received their second dose of the vaccine by IM injection at 2:30 PM 13APR2021 (026B21A). They received their first dose of the vaccine by IM injection on 17MAR2021. They have had no known symptoms, and were observed for 15 minutes after administration of the second dose today.
SO MUCH PAIN AND INFLAMMATION; CAN'T WALK SOME TIMES; KNEES ARE A PAINFUL MESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced so much pain and inflammation, can't walk some times, and knees are a painful mess. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knees are a painful mess, so much pain and inflammation and can't walk some times was not reported. This report was non-serious.
Information has been received from a physician concerning a 6 year old male who was vaccinated with a dose of Varivax. Subsequently the patient broke out with chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. The patient's 3 brothers experienced chickenpox following vaccination with Varivax (WAES# 0605USA04858, 0606USA01456, 0606USA01457). Additional information has been requested.
Patient had one dose of Janssen on 4/2/2021. Patient chose to receive a Pfizer booster on 12/2/2021. On 12/5/2021, patient began to have problems with SOB/cough and went to the emergency room around 7 pm that evening.  Pt was told she had a pulmonary embolism. Pt is now on Eliquis and following up with her PCP.
Admit 8/9/2021 with splenic infarct on their CT imaging. Pt has also recently had cough and was diagnosed with bronchitis by her PCP. Symptoms improved with use of CPAP at home. Her coughing spells at times have left her feeling dyspneic starting 3 days ago. Myeloproliferative leukemia on oral chemo twice daily.  SARS COV2 COVID 19 PCR positive 8/10/21.  SARS COV2 Antibody Nonreactive 8/13/2021.  8/22/2021: discharged Note: patient previously vaccinated with Moderna COVID-19 vaccine, last dose on 6/19/2021.
Covid vaccine vial was not diluted prior to administration  Vial contained 6 doses of 0.3ml
16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees.  These symptoms lasted between 20 and 24 hours.; 16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees.  These symptoms lasted between 20 and 24 hours.; 16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees.  These symptoms lasted between 20 and 24 hours.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 04Feb2021 at 11:00 AM (batch/lot number: EM9810) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took clindamycin and experienced allergies; and BNT162B2 first dose on 14Jan2021 at 10:30 AM (batch/lot number: EL3248) administered in the right arm for COVID-19 immunisation. Facility type vaccine was public health clinic/administration facility. No other vaccine in four weeks. No COVID prior to vaccination and was not COVID tested post vaccination. On 05Feb2021 at 03:00 AM, 16 hours after the vaccination, the patient woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees. These symptoms lasted between 20 and 24 hours. Treatment was received for the events which included over the counter acetaminophen. The outcome of the events was recovered on Feb2021.
No additional AE details; Office manager calling reports expired dose of MMR II was administered to a patient. Vaccine expired 9/4/2022 and was administered 9/6/2022. Product did not experience any temperature excursions through the date of administration. Because caller was; This spontaneous report has been received from an office manager, concerning a identified patient of unknown gender and age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies was unknown.  On 06-SEP-2022, the patient was vaccinated with sterile diluent (STERILE DILUENT) and an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (lot number reported as U007506 which was verified as invalid, expiration date reported as 04-SEP-2022) (strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (expired vaccine used). No adverse events (AE) reported (no adverse event).
patient fainted within 5 minutes of adminstering the vaccine, he looked very pale, his pulse was very high, but he came back within one minute, and was able to maintain conversation...he knew his name and current date. after 20 minutes he walked out of pharmacy with his mom
Swelling from shoulder to elbow, slight fever, BENADRYL 12.5 mg, cool compress.
Within 2-4 days of GARDASIL vaccine - blurred vision bilateral, room spinning - continuous. 3 wks after vaccine - went to ER with dx UTI, URI, ear inf. - and room spinning was relieved. Appt. being made with eye doctor today. Date to be determined. Also c/o headache - intermittent relieved by Ibuprofen.
Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored RECOMBIVAX HB (lot# M037248, expiry date: 21-FEB-2019; lot# L033343, expiry date: 13-SEP-2017) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006087: US-009507513-1703USA000376: US-009507513-1703USA006086.
First three days, my left arm was sore from the shot (normal), Sixth day after, itchiness and slight swelling, no redness.  Seventh day after I had swelling, hardness, redness in large area of arm and still itchy.  Emailed doctor.  No answer yet.  Eighth day, swelling, itchiness, and redness persist.  I have used cold packs and taken IBProphen tablet.  Helps relieve pain a little.
Tdap given on 2-6-12 in (R) deltoid IM - tolerated well. No reaction: noted while in clinic. Called 9 days later stating she had a reaction to the vaccine. Went to ER & was diagnosed with localized allergic reaction with skin rash secondary to drug. (Paper attached) - Upon evaluation of site on 2-17-12 to redness - noted -cool to touch.
Tiredness pain in injection site. Burning joints lightheaded to the point of fainting and vomiting
After injections, client pale - then reports "things are going black". Eyes remained open but not alert. Observed for 30-40 minutes. BP range 92/60 - 80/60, P. 62-80 - thready. Becomes more alert, responsive - taking sips of H20 and juice. Report no breakfast or fluids this AM and swam for 2 hours. Client becomes faint again - recommend ambulance - parent refuses. At 1515 - color returning, responsive - no further occurrence of fainting events. Parents have arranged appt at doctor. 8/21/07 - PC to parents - no further problems - did not see doctor - as were advised by doctor office to keep client cool and hydrate.
21Dec89, 22Jan90, 26Jun90 pt vax w/ hepta B; titer indicated non responder.  recv booster vax on 06Aug90 & titer indicated pt seroconverted.