chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 1 dose / about 4 years ago, but never received a 2nd dose; 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 of shingrix about 4 years ago).   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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received the 2nd dose, which led to incomplete course of vaccination. The patient thought he received shingrix.  He was told that he should come back for a booster in a year after the initial dose, but he forgot about it. When he later remembered, the vaccine was not available when he asked about it. The reporter did not consent to follow-up.
11 years child received Infanrix; Patient got Infanrix instead of Boostrix; Patient received 6th Dtap dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9HP9Z) for prophylaxis.   On 02-JUN-2023, the patient received the 6th dose of Infanrix. On 02-JUN-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 years child received Infanrix), wrong vaccine administered (Verbatim: Patient got Infanrix instead of Boostrix) and extra dose administered (Verbatim: Patient received 6th Dtap dose). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were 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: 06-JUN-2023 The reporter reported that the 11 years old patient received Infanrix vaccine instead of Boostrix vaccine which was the patient 6th Dtap dose, which led to age at vaccine administration, wrong vaccine administered, and extra dose administered. The reporter did consent to follow up via email.
FUSHED SENSATION, DIARRHEA, SORE ARM, ONSET OF PERIOD, BLURRY VISION, VERTIGO, NUMBNESS, TINGLING, MUSCLE FASICULATIONS, WEAKNESS OF LIMBS, EXCESSIVE SWEATING, HAND TREMORS, UNEXPLAINED CIRCULAR BRUISING ON LEGS, SWOLLEN LYMPH NODES, METALLIC TASTE, EXCESSIVE THIRST, INCREASED HEART RATE, MIGRAINES, AND PRESYNCOPE.
severe h/a which is progressively worse & constant p/1st dose of vax; tx Cephalexin for bite;
Patient had a rash that started on the right arm and spread to the legs and truck overnight. Patient contacted her primary care and was advised to take benadryl and pepcid.
I concluded my menstrual cycle a few day before the vaccine and two weeks after the vaccine I began my menstrual cycle again. I?m not sure it?s related to the vaccine but it has never happened to me before. So I thought it would be best to report since if heard similar things from other women. It?s heavier than usual and more painful.  Also I had pain in my left armpit that went away after a few days that started about a week before my menstrual cycle. I?m guessing it was swollen lymph nodes due to the vaccine because I have seen other women report that as well.
This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0164), at the age of 60, via an unspecified route of administration, left arm, on May 15, 2021, at 16:00, single dose, for COVID-19 immunisation. Medical history included no other health issues. The patient does not have any allergies to food, medications or other products. Patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot#EW0158), at the age of 60, via an unspecified route of administration, left arm, on Apr 24, 2021, at 16:00, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 16, 2021, at 10:00, patient experienced temperature of 100.6ºF, chills, weakness, muscle pain, some muscle failure, nausea, vomiting and shortness of breath. No therapeutic measures taken as a result of the events. On May 16, 2021, patient underwent lab tests, which include body temperature and the result was 100.6ºF. The outcome of 100.6ºF, chills, weakness, muscle pain, some muscle failure, nausea, vomiting and shortness of breath: not recovered (at the time of report). No follow-up attempts needed. No further information expected.
Extremely painful at time of injection and arm pain 24-36 hours after injection..  Six days after injection developed bursitis symptons at left shoulder with throbbing pain down to front of bicep and back or bicep areas of arm.  Pain upon raising arm and when pushing arm back.  Pain has been consistent  for 10 days.
Inflamation & muscle pain that continues 6 months after Injection on (L) UE.
little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received Shingles vaccine. On 14-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: little sore). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date:14-jun-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she got the vaccine on day of reporting, it was a little sore but all good. The follow-up could not be possible as no contact details were available.
Within 8 hours of vaccine, developed a temperature of 102F; very fussy and inconsolable X 1 hour.
still got sick; still got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had serious health issues. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jan2023, outcome "unknown" and all described as "still got sick". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 17Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
DIZZINESS- 11/24 and 11/25 (BRIEF SPELLS). HIVES- APPROX. 11/31 AREA OF RIB CAGE, BACK AND ARMS. LASTED 7-10 DAYS.
Pt underwent a syncope 5 minutes after the vaccination. Pt was pale but conscious when notified by the parent, and the vital signs were stable. Pt was laid flat and was able to drink water. History and physical is consistent with vasovagal syncope.  No concerns identified on history and physical.  There is no evidence for this being an anaphylaxis reaction by referred doctor.  The parents admitted that there was some perceived situational anxiety just prior to the injection.  Pt  recovered and left the facility after about 15 minutes observation.
got the shot in the upper arm but on his forearm it looked like he had cellulitis; It was all red and swollen and warm on touch; It was all red and swollen and warm on touch; It was all red and swollen and warm on touch; This is a spontaneous report from a non-contactable consumer.  A male patient (reporter's father) of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated the patient got the shot in the upper arm but on his forearm it looked like he had cellulitis. It was all red and swollen and warm on touch. The reporter didn't know if that's the side effects from the vaccine or not. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Body pain more reminiscent of radiating nerve pain than flu body aches.  Its the worst around my sacrum and radiating down the backs of my legs to the soles of my feet.  I also have pain radiating up my spine over the top of my head and down the backs of my arms to my palms.  My skin is hypersensitive and everything that touches it feels like sand paper.  I started getting chills so bad my hands and feet went numb.
Swollen underarm (left armpit); Swollen underarm (left armpit); discomfort in the area; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 07May2021 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal and cosmetic allergies. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) for allergies on an unknown date and ibuprofen (IBUPROFEN) for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021, the patient experienced swollen underarm (left armpit); discomfort in the area. On 20Mar2021, the patient underwent Oral Swab test for COVID-19 and the result was Negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event swollen underarm (left armpit); discomfort in the area  was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; Wrong vaccine administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 1, single (Lot number: GH9697), in left arm for covid-19 immunisation. The patient didn't receive bnt162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Oct2022, outcome "unknown", described as "Wrong vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2023) Negative; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 05Oct2023 to 10Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300330546 same patient, different SD/AE;
Uncontrollable urine; Severe body aches; Headache; Muscle ache; Possible fever; Chills; Fatigue; Covid like symptoms; Arm pain; Sweats; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), URINE ABNORMALITY (Uncontrollable urine) and PAIN (Severe body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (8 months ago). Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN and ATORVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), PAIN (Severe body aches), HEADACHE (Headache), MYALGIA (Muscle ache), PYREXIA (Possible fever), CHILLS (Chills) and FATIGUE (Fatigue). On 05-Mar-2021, the patient experienced URINE ABNORMALITY (Uncontrollable urine). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 05-Mar-2021, COVID-19 (Covid like symptoms), PAIN IN EXTREMITY (Arm pain), HYPERHIDROSIS (Sweats), URINE ABNORMALITY (Uncontrollable urine), PAIN (Severe body aches), HEADACHE (Headache), MYALGIA (Muscle ache), PYREXIA (Possible fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 30 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Information has been received from a licensed practical nurse (LPN), via company representative, concerning a 16 year old female patient with a sulfonamide allergy, who on 26-Mar-2007 was vaccinated with a dose of 0.5ml, IM, of Gardasil (Lot # 656372/0243U). Concomitant therapy included LOESTRIN. The nurse reported that on 26-MAR-2007, "about 15 minutes" after the vaccination, the patient felt dizzy, passed out, "hitting her face and head as she fell." The patient was taken to the ER, and was treated wit intravenous fluids and TYLENOL. A computed tomography (CT) was performed to evaluate for head and neck injury; the CT result was negative. The nurse added that the patient also developed a low grade fever (date not specified). At the time of this report, the nurse indicated that the patient had recovered from the events. Felt dizzy, passed out, hitting her face and head as she fell, and low grade fever were considered to be an other important medical event. Additional information has been requested.
pt recv vax & returned home w/ mom; in pool,suddenly had a high pitched, inconsolable scream,lasting 10 mins;pt went limp;was not arousable to voice or moderate shaking;would shake every 7 min; to er;infant aroused & exam nl in er;
Rashes; Rapid heart rate; Feeling unwell; blisters; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZE-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 27Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced rashes, rapid heart rate, blisters and feeling unwell. She experienced allergic reactions during the 1st dose (taken last 27Jul2021) of Covid-19 vaccine. She said that she experienced blisters or rashes, rapid heart rate, and feeling unwell. She added that her employer requires her to complete the doses of the Covid-19 vaccine but she wanted to have an exemption for it because of the adverse events that happened after the 1st dose. She also mentioned that this concern has been already reported. She wanted to know how to be exempted for not getting the vaccine 2nd shot. The outcome of evens was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a 51 year old female consumer, referring to herself. The patient's medical history included three previous cases of shingles. On an unspecified in January 2015, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose, frequency, lot # and expiration date were not reported). No concomitant medications were reported. On approximately 09-SEP-2015 (also reported as approximately 3 weeks ago), the patient developed her fourth case of shingles. The patient went to see her primary care provider who treated her with a MEDROL dose pack, but the shingles  did not improve. At the time of the report, the patient stated she was still experiencing the effects of shingles. No product quality complaint was involved. Additional information is not expected because no reporter's contact details were provided.
Client states that she experienced pain at the site of injection in her left arm. Client states during the middle of the night on 03/08/2022, she awoke with a stiff left arm and she had difficulty moving her limb. Client states that muscle spasms began in her left arm on Friday, March 11th, as well as symptoms consistent with a pinched nerve in the right buttock. Client has not seen a physician since her pre-vaccination telehealth visit on 03/08/2022. Client declines seeking emergency medical evaluation, declines contacting her physician, and states that she is experiencing worsening symptoms of pain and muscle spasms related to her diagnosis of Reflex Sympathetic Dystrophy Syndrome (RSDS). Client rates pain on 03/08/2022 as 7/10 and rates pain today, 03/14/2022 at 3-4/10. Client states that she has a high pain tolerance and states that she has implants in bilateral hips for spinal cord stimulator. This nurse referred the client to be evaluated by her PCP or neurologist.
2 hours after vaccine, became drowsy. 4 hours after vaccine - trouble breathing, chest pain, weakness, partially incoherent, flushed face.
Vaccine received on 1/6/2021 at 0810.  Symptoms of fever (tmax 102.5) and body aches began at 18:00 on 1/6/2021.  Still has fever but improves with tylenol.
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient states has been applying benadryl 2% cream to the injection site and will try hydrocortisone 1% cream as well for the itching.  She will take benadryl once she gets home.
Sore arm at the injection site; Lymph nodes to swell and became more tender and continuing to swell into her breast area; Her 1st and 2nd dose and she states that she didn't get Pfizer, she did Johnson and Johnson; Her 1st and 2nd dose and she states that she didn't get Pfizer, she did Johnson and Johnson; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) on 02Nov2021 via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history included cancer patient with a double mastectomy. There were no concomitant medications. Prior to the vaccine patient received two historical doses of Johnson and Johnson vaccine. On 02Nov2021 patient experienced Interchange of vaccine products and off label use. On 03Nov2021 sore arm at the injection site and lymph nodes to swell and became more tender and continuing to swell into the breast area. Anti-inflammatory therapeutic measures were taken because of lymph nodes to swell and became more tender and continuing to swell into the breast area.The outcome of the events Interchange of vaccine products and off label use was unknown. The outcome of the events vaccination site pain and Lymphadenopathy was not recovered.
This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a patient who received Influenza vaccine. In 2015, the patient received Influenza vaccine. In 2015, an unknown time after receiving Influenza vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Influenza vaccine. Additional details provided were as follows: The healthcare professional reported that,, the patient might had experienced an adverse event after the vaccination.
Fever 103, not reduced by acet. or ibuprofen for 48 hours, swelling at injection site with pain
4 hours after vaccine, severe chest pain and very high blood pressure. Lasted over an hour.
On Monday 05/30/2022, I started having trouble breathing, dizziness, fatigue, and low-grade fever. When I woke up the next day, I had congestion and pressure around my eyes. I went to my doctor after these symptoms on 06/01/2022, and got COVID-19 tested. They performed a rapid antigen test, and it came back positive. The doctor prescribed me Paxlovid and prednisone 20mg. Currently, I'm still having congestion and everything because I just started the medication today (06/02/2022).
Immediately after receiving influenza vaccination on Dec 7, 2019, felt pain in the arm (left) and felt numbness in the face on the left. Symptoms resolved within 24 hours.