chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; body was sore; nipples have been sore/nipples on my breast are tender; breast is still sore; arm was sore; This is a spontaneous report from a contactable consumer (herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955), dose 2 via an unspecified route of administration, administered on Arm Left on 25Mar2021 10:45 as DOSE 2, SINGLE for covid-19 immunisation (at an age of 54 years). Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing and contrast media allergy (Iodine with contrast) from an unknown date and unknown if ongoing. Concomitant medication included drospirenone (SLYND) and patient had green pills after dose 2 of vaccination. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247), dose 1 via an unspecified route of administration, administered on Arm Left on 03Mar2021 14:15 as DOSE 1, SINGLE for covid-19 immunisation received other vaccines within 4 weeks prior to this COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No medications received within 2 weeks of vaccination. The patient took her second vaccine on Thursday. The next day about 23 hours later on 26Mar2021 at 11:00 she felt very tired and her body was sore. Her concern is that her nipples have been sore since Friday. She took Slynd 4mg everyday. She was concerned because her breast has not been sore in the past. Today is Monday, March 29, 2021 and her breast is still sore if she touch it. Note: on 26Mar2021 her arm was sore with both shots which she know is a normal side effect. Also, she aware that being tired and her body being sore is another side effect. Her concern is that her nipples on her breast are tender. This is something new that she have not experienced in years. No treatment measures were taken in response to events. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient presented to the ED and was subsequently hospitalized for diarrhea, acute kidney injury and syncopal event within 6 weeks of receiving COVID vaccination.
12-15-2011 clinic visit for Tdap reaction. Arm with 9x11 cm erythema; increased warmth, no induration.
Super High Fever on Sunday; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Super High Fever on Sunday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE in March 2021 and PFIZER BIONTECH COVID-19 VACCINE in April 2021. Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (Super High Fever on Sunday). In 2021, PYREXIA (Super High Fever on Sunday) had resolved. Not Provided          No information on concomitant medication were reported. It was reported that patient had super high fever on Sunday and completely back to the normal on Monday. And stated it was worth. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Received Tdap vaccine 4/7/11 left deltoid - c/o shoulder pain at site continues limiting range of motion shoulder - started day #2 - no fever, no redness, no swelling - no pain at rest - hard to lift arm up - referred to PCP & take Ibuprofen.
Cold Chills, Felt like I had a fever but no fever, joints ache, headache lasting one day
This spontaneous report as received from a consumer via Clinic refers to a currently 74 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Caller states that it has really been rough on them, especially her husband. Caller repeats that it has been really hard on the body.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 02Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose.), for COVID-19 immunization; Bnt162b2 (Second dose.), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 02Oct2021, outcome "unknown", described as "Caller states that it has really been rough on them, especially her husband. Caller repeats that it has been really hard on the body.".  Follow-up (15Nov2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
developed patches of rash; developed aches; chills; fevers; her arm is still sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8734; Expiration Date: Jul2021), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included influenza from an unknown date and unknown if ongoing it occurred 20 years ago. Mentioned allergy to Flu shot on initial report. Has no NDC/LOT/EXP for Flu shot and it occurred 20years ago. She doesn't think she is allergic to the things in the COVID shot. She was allergic to the flu shot. Was told to never take the Flu shot again. The patient's concomitant medications were not reported. Patient received her first dose of the Pfizer BioNTech COVID-19 vaccine 36 hours ago. Approximately 7 hours later she developed patches of rash here and there and developed aches, chills, fevers and her arm is still sore. The outcome of the events was unknown. Requested medical information if there is something she can take before the second COVID shot so the side effects are not as bad like a Benadryl.  No follow-up attempts are needed. No further information is expected.
After the vaccine I experienced soreness in the arm and  minor swelling shortly after, Wednesday afternoon I had an upset stomach , Thursday I was experiencing fatigue that I have never felt before. I called my doctor and was able to be seen Friday morning and my blood levels were at a 10.4 which is low but not for me. I had no appetite I just couldn't get up to do anything. The following day I actually had a good nights rest and felt much better in the morning.
Within 10mins or receiving the vaccine client experience light headedness and blurred vision. this quickly progressed to her having severe chills with violent trembling and a sudden severe headache. She with disoriented, BP elevated and experience acute delirium. She was assessed and treated in the ER with Hydralazine and IV fluids.
Tinnitus onset in both ears. Noticeable after 10 days. Has not resolved or lessened since onset. I have had no previous history or family history.
I have only menstrual once since receiving my second dose of the Pfizer COVID-19 vaccine. Prior to vaccination my menstruation was regular and predictable very month without concerns of amenorrhea.
Site: Pain at Injection Site-Medium, Systemic: burning pain-Medium, Additional Details: burning pain after shot given. referred to clinic NPs (2) we have on site. shot given IM at left deltoid.
Fever; Fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that:  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, lot Number: Ew0183) via intramuscular, administered in Arm Right on 07Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: Ew0177), via intramuscular, administered in arm Right on 15May2021 as dose 1, single for covid-19 immunisation. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 07Jun2021, the patient experienced fever and fatigue. Therapeutic measures were taken as a result of the events using Ibuprofen. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
received 3rd dose on 01-NOV-2023; Engerix-b/ Late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 20th March 2023).   On 01-NOV-2023, the patient received the 3rd dose of Engerix B. On 19-SEP-2023, the patient received the 2nd dose of Engerix B. On 19-SEP-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Engerix-b/ Late second dose). On 01-NOV-2023, the patient experienced drug dose administration interval too short (Verbatim: received 3rd dose on 01-NOV-2023). The outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reporter was a healthcare professional at a clinic.  The interval between the second and the third dose of Engerix-B was 6 weeks.  The reporter asked for guidance on patient schedule. There were no symptoms at this time. The patient received 2nd dose of Engerix-B later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix-B earlier than the recommended schedule, which led to shortening of vaccination schedule.
really severe heartburn, to the point of tears. I never have heartburn but google told me to eat tums & drink baking soda in water so I did that. At time of writing I've had the really bad heartburn for nearly 7 hours
Fever, chills, severe headache, extremely swollen lymph node under armpit of the arm vaccinated
102.8 fever, body aches leg feet cramps, nausea, headache, neckache
Resident received his 2nd vaccination 7 days earlier than the recommended 28 days.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 83-year-old female patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site wheal and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site wheal were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site wheal and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient experienced pain at injection site which had resolved. The patient reported that even after 2 weeks, she still had swelling, redness, and a hard welt on her injected arm. The size was about 1 inch below the site, and 1 inch above. The patient had denied permission to contact their physician. The caller did not wish to participate in a safety report.
Information has been received from a pharmacist and refers to a patient (age and gender unknown). Information about medical history, current condition and concomitant therapy was unknown. On 12-JUL-2018, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 (route, strength and frequency were unknown; Lot number N037669 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date: 09-MAY-2018) for prophylaxis (expired product administered). No adverse effects were reported.
This spontaneous report was received from a pharmacist and refers to a 73-year-old female patient with no drug reactions or allergies and unknown pertinent medical history. The patient's concomitant therapies included ibandronate sodium (BONIVA), pantoprazole sodium (PROTONIX), acetaminophen (TYLENOL) and ibuprofen(MOTRIN). On 26-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 in her left arm, lot number N000463 with expiration date 19-OCT-2018 (route and dose were not reported) as the patient was on age to receive the vaccine. On 26-SEP-2017, the patient developed swelling of left arm "up to her armpit and a red streak under her left armpit" (peripheral swelling and erythema). The patient began to take unspecified doses of acetaminophen (TYLENOL) and ibuprofen (MOTRIN) as treatment. No laboratory diagnostics were performed. At the time of the report, the outcome of the peripheral swelling and erythema was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported.
She started with tachycardia after receiving 2nd dose of moderna vaccine in March/Now July and she still has that problem; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (She started with tachycardia after receiving 2nd dose of moderna vaccine in March/Now July and she still has that problem) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TACHYCARDIA (She started with tachycardia after receiving 2nd dose of moderna vaccine in March/Now July and she still has that problem). At the time of the report, TACHYCARDIA (She started with tachycardia after receiving 2nd dose of moderna vaccine in March/Now July and she still has that problem) had not resolved.            Concomitant medication use was unknown. Treatment information was unknown.
Headache, Myalgia, Arthralgia, NauseaVomiting,  Fatigue, Chills, "Feels like been hit"
vaccine received 07/5/2007 received phone call 7/7/07 from pts husband stating that pt has been sick and they are concerned if related to rabies vaccine symptoms started two hrs after receiving vaccine pt has had chills, fever, diarrhea and has been vomitting.  pt is taking motrin and immodium for pain and diarrhea.  husband states they are concerned she is not improving.  Husband states pt uses gwinnett clinic for medical care, encouraged to take pt to gwinnett clinic or emergency room.  07/09/2007 spoke with pt she reports she did not seek medical attention and is feeling better now.
Information has been received from a nurse practitioner concerning a 6 year old white female who on 07-JUN-2000 was vaccinated in the left upper arm with the first dose of varicella virus vaccine live (Lot# 632619/1861J). The NP reported that in 01-AUG-2005, the patient developed mild breakthrough varicella characterized by 20 - 30 vesicular lesions scattered among her chest and back with a few on her arms and legs. No other symptoms were noted (no fever or body aches) and the lesions were also noted to be non-pruritic. Unspecified medical attention was sought. Subsequently, the patient recovered from the breakthrough varicella. Additional information is not expected.
Suspected vaccination failure; Shingles; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On 17th December 2018, the dose was an unknown dose. On 17th December 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 6th July 2019, 355 days after receiving Shingrix and 201 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain in arm. The patient was treated with acyclovir (Zovirax) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced sore arm that lasted for about 3 days after Shingrix dose 1 and dose 2.  On 6th July 2019, the patient broke out with Shingles rash on middle of stomach to the chest and to the right side of the body to the middle of her back. The patient went to see her doctor on 9th July 2019, and she was diagnosed with a case of Shingles. The patient was prescribed Zovirax 500 mg five times a day for 7 days and that did not work, so she was then given Valtrex 800 mg four times a day for a week. The patient condition has improved but not resolved completely. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of herpes zoster were unknown at the time of reporting. The reporter was consented to follow up. No further details were provided. For 1st occurance of soreness event refer case US2018192677 (same patient)
Swelling from of right leg from hip to knee; botchy red area on upper thigh, not directly around injection site.
Blood pressure shot up to 248/100?? Not sure of the bottom number. everything was happening so fast. it eventually came down gradually after about 20 minutes. my blood pressure was taken about seven or eight times. it did come back down to normal or a little above normal 135/90
Information has been received from a physician concerning a 15 year old female with migraines and tension headaches who in January 2007, was vaccinated intramuscularly into the right leg (also reported as "buttocks") with a first dose of GARDASIL. Concomitant therapy included amytripaline (manufacturer unknown and rizatriptan benzoate. In March 2007, a second dose of GARDASIL was administered intramuscularly into the left leg (also reported as "buttocks"). The physician reported that "a few days to a week after each dose the patient developed a sciatic neuropathy". It was further reported that the neuropathy of the right leg had resolved completely over a few weeks (approximately January 2007 or February 2007). The neuropathy of the left leg had improved, but has not resolved. The physician noted that the patient was still having weakness in the left leg and loss of deep tendon reflex at the level of the left ankle. She also had sensory complaints and tingling when touched at the lateral distal lower extremity. The pain was improved however. The patient was reported to still have a limp. It was also reported that the patient was able to attend school but was unable to participate in physical activities due to the sciatic neuropathy. The physician felt that the patient's experiences were disabling. Additional information has been requested.
This spontaneous report as received from an unknown source via company representative referred to a 53 year old male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose not reported) (Batch# H019037, expiration date unknown). Concomitant medication, medical history and drug reaction/allergies were not reported. On an unknown date the patient developed a 22 cm x 19 cm whelp. The outcome of the event was unknown. The patient sought for medical attention, spoke with the original HCP. It was unknown if the patient received treatment. This is one of two reports from the same source. Additional information is not expected.
pt recv vax 6DEC96 & 25DEC96 pt devel a fever to 103 & chickenpox w/approx 30 lesions;pt recovered;
Increasing, swelling, redness, and pain after anthrax shot. #5 Anthrax the worst yet.
Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose; 31AUG2021 3 rd dose and 20-feb-22 booster dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose) and EXTRA DOSE ADMINISTERED (31AUG2021 3 rd dose and 20-feb-22 booster dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 020F21A, 018B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (Joint pain in the past) and Joint swelling (Joint swelling in the past). Concurrent medical conditions included Osteoarthritis, Psoriatic arthritis and Alopecia (Patient has not had any changes to her alopecia.). Concomitant products included METHOTREXATE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (31AUG2021 3 rd dose and 20-feb-22 booster dose). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose) and EXTRA DOSE ADMINISTERED (31AUG2021 3 rd dose and 20-feb-22 booster dose) outcome was unknown.            Patient received fourth Moderna COVID-19 vaccine (Booster dose). Prior to receiving all of these doses she stopped taking her methotrexate. Her arthritis symptoms also improved after the 4th dose which was a booster. She continues to have no pain today and has not restarted her methotrexate since receiving the 4th dose. No treatment information details were reported.   This case was linked to MOD-2022-496953, MOD-2022-496958, MOD-2021-079053 (Patient Link).