chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has red bumps on stomach, legs & back. Sm Qtip size red raised bump on VARICELLA site right leg and PREVNAR site is a bruise. Pt feels well. Pt has slight fever & fussiness since 2/18/9.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. Approximately 13 patients who received a dose of SHINGRIX. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that any cases were confirmed cellulitis, but 3 of the patients did voluntarily seek treatment from a physician and the other 10 cases resolved spontaneously. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. The clarification requested for case creation and event coding.
bleeding all over; allergic reaction to the shot; lot of pain in her joints (hip pain); lot of pain in her joints (hip pain) and muscles; Initial information was received on 01-May-2023 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case is linked to case 2023SA138901.  This case involves 78 years old female patient who experienced bleeding all over, allergic reaction to the shot, lot of pain in her joints (hip pain) and lot of pain in her joints (hip pain) and muscles, after receiving vaccine tetanus toxoid and while treated with amoxicillin.  The patient's past medical history included Animal bite. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included  for Allergic reaction.  On an unknown date, the patient started taking amoxicillin (form, strength, dose, frequency, batch number, expiry date: unknown) for unknown indication.  On an unknown date, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer (lot number, expiry date: not reported) via unknown route in unknown administration site (form, strength: unknown) for prophylactic vaccination.  On an unknown date the patient developed a serious event of bleeding all over (haemorrhage) (unknown latency) following the administration of tetanus toxoid and (unknown latency) following the first dose intake of amoxicillin.  On an unknown date the patient developed non-serious events of allergic reaction to the shot (hypersensitivity), lot of pain in her joints (hip pain) (arthralgia) and event of lot of pain in her joints (hip pain) and muscles (myalgia) following the administration of tetanus toxoid and (unknown latency) following the first dose intake of amoxicillin.  Patient got a tetanus shot and was on Amoxicillin. Patient developed an allergic reaction after 5 days of taking Amoxicillin and stopped taking the antibotics.  No lab data reported.  Action taken with tetanus toxoid was not applicable. amoxicillin was discontinued on an unknown date.  The patient received loratadine (Claritin) and cetirizine hydrochloride (Zyrtec) for Allergic reaction. It was not reported if the patient received any corrective treatment for other events.  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria: medically significant for the event haemorrhage.; Sender's Comments: Sanofi company comment dated 10-May-2023: This case involves 78 years old female patient who experienced bleeding all over, after receiving vaccine tetanus toxoid and while treated with amoxicillin. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
TIREDNESS/ MUSCLE PAIN/ STOMACH PAIN/ HEADACHE/ HEART BEATING FAST/ SHIVERING/ FEVER/ NAUSEA
respiratory distress and wheezing treated with albuterol nebs, zithromax 133mg daily, Omnicef 180mg daily prednisolone 13mg daily patient discharged home on 8/28/22
I felt fine the whole until December 27th. I had a TIA mini stroke. Then on December 28th I had a stroke and I was hospitalized for 7 days. Then I spent 5 days in a rehab facility.
devel cold chills, rigors, night sweats, joint pain, headache & fever;treated w/septra DS + tximethoprim, tylenol, motrin;7/1 60% improved;disorientation & dizziness caused fall;7/13/99 diarrhea & passed out w/ loss of consciousness x 7min;
Pt complain of ache/pain, chills, "flu like symptoms" after vaccination.
This spontaneous report as received from a certified medical assistant refers to an unspecified patients. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL (doses and lot numbers were not reported), oral. This is one of several reports received from the same source. Additional information has been requested.
Was 5.5 weeks pregnant. Had the shot, felt strange that night, miscarried the next day.
2 days after shot given, leg became red, hot, and swollen. Given Benadryl orally and hydrocortizone topically
It started out with pimples. I thought they were spider bites. They would go away in a few hours. That continued for like 3 weeks. Then I started having some blisters in my legs, bottom area, arms. They looked like water blisters. They itched terribly. I took some Benadryl for a couple of days. After a week or so I thought I should see a doctor. I made an appointment and they said they did not know what it was. They told me to buy an over the counter medication. They come back daily. I have another appointment with my doctor on 09/22/2021.
Janssen COVID-19 Vaccine EUA Developed a headache and sore arm approximately 12 hours after vaccine administered. The headache lasted for 5 days.  I currently still have a walnut-sized, firm lump in my arm at the injection site that is still slightly painful (like a mild bruise). The skin surface of the injection site was itchy (like a mosquito bite) on 3/22 and 3/23. My main concern is the continued presence of the lump in my arm.
arthritis started acting up real bad/worsening of arthritis/just reacted in her body/bad reaction with Enbrel and her covid-19 shot/started to have a reaction; took Enbrel at a dose 50 mg, every other week, which was off label use; This serious spontaneous report (USASP2022202388) was reported to company on 21/NOV/2022 by a consumer and involves a female patient whose arthritis started acting up real bad/worsening of arthritis/just reacted in her body/bad reaction with enbrel and her covid-19 shot/started to have a reaction [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Syringe. Off label use was reported. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis, high blood pressure, diabetes. The patient's concomitant medications included Cimzia (certolizumab pegol).The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date in 2018. From an unknown date in 2018, the patient took Enbrel at a dose 50 mg, every other week, which was off label use. The patient took the COVID-19 (coronavirus disease of 2019) shot on 17/MAR/2021. When she took her Enbrel on 18/MAR/2021 and started to have a reaction. On an unknown date in MAR/2021, the patient had a bad reaction with Enbrel and her covid-19 shot. The patient took the covid-19 shot and Enbrel the same week and it just reacted in her body. The arthritis started acting up real bad/worsening of arthritis. The patient stopped Enbrel on an unknown date in MAR/2021. The patient reported that now she tried something new for her rheumatoid arthritis. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Syringe was withdrawn on an unknown date in MAR/2021 for the event rheumatoid arthritis. The consumer reported that the event rheumatoid arthritis was possibly related to Enbrel. The causal relationship between the event rheumatoid arthritis and Single Dose Prefilled Syringe was not provided by the consumer. The reporter did not and would never have access to lot number. No further information has been requested.  Comment: This safety report does not necessarily reflect a conclusion by company that etanercept, single dose prefilled syringe, caused or contributed to the adverse event(s) reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  Enbrel is under agreement with company.
injection site pain and soreness; Myalgia; fatigue; Headache; GI cramps; Nausea; Fever 102; This is a spontaneous report from a contactable Pharmacist (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on an unspecified date at single dose for covid-19 immunization. Past drug history includes syeda for polycystic ovarian syndrome (PCOS). The patient's concomitant medications were not reported. On an unknown date, the patient experienced injection site pain and soreness, myalgia, fatigue, headache, GI cramps, nausea, fever 102. Patient took acetaminophen for symptoms. It was reported that event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever; Chills; General body pain; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: 31Mar2021) on 07Jan2021, via intramuscular at single dose for COVID-19 immunisation. The patient medical history reported as none. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 for COVID-19 immunisation. It was reported that the patient received second shot today (07Jan2021) and now she was feeling, having fever and chills and just general body pain, so she just wanted to report her symptoms, there is a website so she was just calling and asking if she should just take regular Tylenol. She got the shot on 7th (Clarified as 07Jan2021) in the morning and its night there, so she got the fever at night (Clarified as 08Jan2021). She didn't have any symptoms right away. As treatment, patient just took Tylenol. The outcome of the events was not recovered.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-NOV-2022 Reporter's Comment: The registered nurse reported that inadvertently a dose of Havrix given to the patient into left deltoid in their facility and it was already expired.  The reporter asked any efficacy information and should patient be revaccinated. The reporter did not consent to follow up.  Additional Supportive Information: The use of Havrix dose, which was already expired on 30th September 2022, which led to expired vaccine used.
Shortly after I received the first vaccine, a small bump grew on the left side of my nose bridge.  It continues to get worse after the second dose, and progressing to more hardened tissue under the skin of my nose bridge.  My nose bridge becomes bumpy with uneven skin texture.  I have an implant in my nose for over 30 years, I received many different vaccines, but nothing like this happened in the past.  It is possible a foreign body response to the implant due to the hyperactive immune response to the vaccines.  Foreign body responses can happen to all implants, including pacemaker, IVC filters etc.  It may cause implant failure due to the fibrosis growing around the implants.  Fibrosis and implant failure should be monitored in the vaccine safety survey, and the vaccination guidelines should give guidance to adjustment of dosage and frequency to avoid catastrophic consequences.
Lymph nodes of the left arm are swollen/ major swelling; Chills; Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Lymph nodes of the left arm are swollen/ major swelling), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness in the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph nodes of the left arm are swollen/ major swelling), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness in the left arm). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Lymph nodes of the left arm are swollen/ major swelling) had not resolved and CHILLS (Chills) and VACCINATION SITE PAIN (Soreness in the left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported by the reporter.  As of 14-May-2021, the patient was doing fine and she took her second dose on an unknown date and confirmed that there were no events after her second dose. On 29-Jun-2021, the patient reported that it had been close to 2 months and she still had major swelling in her left arm lymph nodes.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up report received on 14-May-2021 included information about outcome of events and information of second dose was added. On 29-Jun-2021: Follow up report received on 29-June-2021 included reporter's email address and event outcome was updated to not recovered.
17 years old daughter received the Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old daughter received the Moderna Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old daughter received the Moderna Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old daughter received the Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
I had some reactions to both shots (Moderna) which resolved within a few days including fatigue, headache, sweats and chills. My primary concern at this point is what occurred two weeks after my second shot starting on Sunday, June 13th when I was overcome with dizziness, vertigo, nausea and vomiting. I was unable to lie down and had to stay propped up. I experienced some sweating and deep chills through the night. I went to see Dr. I am still experiencing vertigo, ringing in the ears, and headache. I have to walk slowly, am not driving. On 6/17/21 I got a prescription for Meclizine but it makes me too tired to stay awake. I have missed almost an entire week of work. My next avenue is to pursue physical therapy to see if my ear crystals are off or being affected in a way that can be remedied. Since these symptoms occurred along with deep chills and some sweats my Dr. and I are thinking this is related to the vaccine. I have never experienced these type of symptoms before.
Burning sensation throughout body. Some tightness in throat difficult swallowing at times. Feel like my Blood is boiling. Watery eyes some. burning feeling not going away.
Severe pain; The initial case was missing the following minimum criteria: unspecified patient and event. Upon receipt of follow-up information on (03Sep2019), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: X70865) intramuscularly (IM) on 09May2019 at a single dose for routine shot (immunization). The patient's medical history was not reported. There was no concomitant medication. The patient experienced severe pain on an unspecified date. The outcome of event was unknown.
Ten days after the vaccine I started having involuntary twitching of my arms and legs . It was bilateral, a single twitch every ten minutes or so all day long.  I am still  having the twitching in my arms and legs hourly after 11 weeks. I also have insomnia nightly, a brief waking one or two times a night also still happening after 11 weeks. My left ear had a crackling sound that came and went a couple of times a day. which is now happening a couple of times weekly. Starting on day 14 I had severe breast pain for three days. I have been trying multiple forms of naturopathic treatment to help and the symptoms have improved slightly. I plan to see a Neurologist.
mother notes that child arm was sore and tender, had bruising and then became swollen.  The red area seemed to be spreading.  They presented to ER.  they were treated and d/c'd home.
If changes to menstruation with the girls could be like a reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), administration date: Dec2021, for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), administration date: Dec2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "If changes to menstruation with the girls could be like a reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200398491 same reporter/drug/event, different patient
Abdominal cramping and diarrhea four hours after receiving shot. Fever gradually reached 104 degrees at 22 hours after shot (despite taking fever-reducing medication). Other symptoms persisting at 50 hours post shot: muscle and joint pain, headache, fatigue, throat irritation, increased heart rate, fatigue, fever abdominal cramping and nausea.
About 20 hours after the (2nd) shot I got up from my chair after watching the 6:30 PM News and walked about 4  steps and had a breathing "seizer." I could not get any oxygen and in a near panic tried to hyperventilate. After 45 sec I was able to walk another 4-10 steps but the seizer occurred again. Took me 5 minutes to get from the living room to the kitchen and then another 5 to get to the bedroom. In the morning I was reasonably "fine."  but then had flu like systems for 1.5 days and then was totally over it all.
Dizziness, Headache, Myalgia, Arthralgia, fatigue, chills Narrative:
12 days after receiving Moderna on 4/16/21, pt reported shortness of breath (4/28/21). She started using her nasal steroid (fluticasone) daily and started to feel a little bit better. She then developed swelling of her toes and generalized weakness necessitating a trip to urgent care on 5/21/21. She was treated with an antibiotic for UTI and gout with a prednisone taper. The prednisone helped with the swelling of her toes and feet, but when she finished the steroid course, swelling returned to her feet. She contacted my office and explained her situation. Gout was diagnosed clinically but not with any lab work up. Pain and swelling migrated from one foot to both foot and she had some neuropathic pain significantly limiting mobility. Pt was started on ibuprofen and then added Cymbalta with minimum-moderate improvement. Work up for gout, hepatitis, rheumatoid arthritis, lupus, were negative but ESR and CRP were elevated. Had to give a temporary handicap placard due to limited mobility. Started patient on methotrexate/folic acid on 6/15/21 and am titrating dosing up as needed, currently on 12.5 mg/week.
Left thigh has 11 X 14 cm redness and warmth. It was a local reaction. Treatment was cool compresses and Tylenol or Ibuprofen.
Sore neck and arm, neck pain relieved but arm pain worsened. Tried ice, heat, and ointments with no relief of sharp pains.