chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on both her arms and it itched; a little bit of a rash on both her arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]), BALSALAZIDE, CARBAMAZEPINE, CLONAZEPAM, APIXABAN (ELIQUIS), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), METHOTREXATE and CALCIUM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms). In 2021, RASH PRURITIC (rash on both her arms and it itched) and RASH (a little bit of a rash on both her arms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported. It was reported that a couple of weeks later the events went away pretty much.   This case was linked to MOD-2022-467166, MOD-2022-467167 (Patient Link).
Very bad headache, left work at 3pm got home fever of 104, sweating weak, chills its 10/8 still with severe headache and chills nausea, diarrhea still very sick.
This case was reported by a pharmacist via call center representative and described the occurrence of ear pain in a 78-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 12th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced ear pain. On an unknown date, the outcome of the ear pain was unknown. It was unknown if the reporter considered the ear pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient complained of ear pain starting after she received SHINGRIX vaccine on Tuesday. The pharmacist reported via chat that they might have reported events related to the patient.
Site: Pain at Injection Site-Mild, Systemic: Arm tingling/numb-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient appeared extremely anxious when going to admit the vaccine. After 115 minutes of monitoring the patient explained she was feeling tingling down her arm. She said she has covid in the past and claimed that "any side effects that occur she was bound to get." She insisted on us calling 911 and was put on a stretcher in an ambulance
I started spotting, blood coming from the vagina. I went to the gynecologist and the first time she didn't do anything. Just a biopsy. I noticed that it got worse, and I went back to her and we did a second biopsy and then she sent me to the lab and they did an ultrasound- microscopic examination. Gyn-Transvaginal U/S. The results that came back is that I had stage 1 uterus cancer. So, I came to the (withheld), and the doctor performed surgery on January 5, 2022 and I had a hysterectomy. And following up with radiation next week. I didn't have any allergies before either and now I'm having allergic reactions to either fish or shellfish. but I was itchy for 3 weeks straight and I'm not sure if that's from surgery or something else. Radiation is a preventative measure so that the cancer doesn't come back.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2018SA289714, 2018SA289594, 2018SA289611, 2018SA289640, 2018SA289651, 2018SA289731, 2018SA289688 and 2018SA289702. This case involves a 4 years old male patient who was vaccinated with a dose of IPOL (lot N1K931M via unknown route in unknown administration site) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that nine doses were indeed given out of an opened multi dose vial of IPOL after the temperature excursion which reached 32.76 F for 19 hours 44 minutes. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Two straight days of maintained fever between 100.9 & 102.2, full body shaking/chills, muscle cramps, nausea.
Patient received J+J vaccine at 1028am and had vomiting at 1050am
Patient received two doses of Fluad (flu shot for 2020-2021) first on 8/30/21 and a second and extraneous dose on 9/24/21. The patient filled out both vaccine immunization consent forms requesting a flu vaccine. She did not report any symptoms or side effects.
Case number PHEH2015US013490 is an initial spontaneous report from a healthcare professional received on 08 Jul 2015, with follow up report received on 28 Sep 2015. This report refers to a 12 year old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with MENVEO (batch number: A14070, expiry date: Nov 2015) subcutaneously into right deltoid which was stored at a temperature below recommended range at a dose of 0.5 ml on 29 Jun 2015. No adverse event reported following this medication errors. Follow up report from a healthcare professional received on 28 Sep 2015: New event was added. Site of administration and dosage of MENVEO was updated. Follow up report from a healthcare professional received on 4 November 2015: The patient had no concomitant medication and no adverse event following subcutaneous administration of 1st dose of MENVEO.
Patient is experiencing fatigue, syncope, muscle aches, runny nose, headache, lips are getting dark. No SOB voiced. Recommended to take Tylenol, stay hydrated and an OTC antihistamine, as for the lips becoming dark, I recommended for her to see a medical provider. 4/22/21- Follow Up: Patient stated she is still not feeling so well because of the cramps all her symptoms have subsided besides the nerve pain in her body. She only took tylenol and and takes it every morning and night and it has been helping.  She didnt go to an ER/Urgent but she is going to see her PCP on 4/22/21.   Advised to continue with the tylenol and will call back on Friday 4/23/21 to follow up and see what PCP advised.4/24/21- Follow up- patient stated she is feeling better and all her symptoms have subsided with the tylenol, no pcp/er visit.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-JUN-2011, the patient received improperly stored VARIVAX dose 2, from lot # 669223/1564Z, expiry date 11-NOV-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
pt became light headed and she stated that she could not see or hear for about 30 seconds. after 30 seconds or a minute she said that everything returned to normal. this happened about 5 minutes after administration. 911 was called and pt was checked out. all vitals were fine and pt remained with her parents.
Information has been received from a physician concerning a 20 year old female with anxiety disorder and a history of papanicolaou smear abnormal and positive for HPV that resolved with no treatment and no drug allergies who in June 2008, was vaccinated with the third dose of GARDASIL vaccine (yeast). Concomitant therapy included PROZAC. On 18-JUN-2008, the patient had a Papanicolaou (PAP) that was positive for HPV. Medical attention was sought via office visit. No product quality complaint was involved. Additional information has been requested.
Starting the evening of 08/17/2022, I started running a fever and felt cold and was shivering. It was around 102. I tested myself because I had been to the dentist recently and was concerned of exposure. It was negative. The next morning I woke up and felt awful with a bad sinus headache, chills, fever, body aches and extreme tiredness. I tested myself 2 times and both were positive. So, I called my doctor right away and he prescribed me Paxlovid. I started it the same day. My symptoms started to improve by Sunday morning (08/21/2022). My sinuses felt better and I was no longer running a fever. Today (08/22/2022) I am feeling much better just slightly dizzy but attribute that to the Paxlovid. I took 2 at-home COVID-19 tests this morning and both were negative. Also, Paxlovid leaves a "horrid" taste in the mouth.
No adverse effects reported; the patient inadvertently received an expired dose of MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-AUG-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) injection, lot # N023146, expiration date: 24-AUG-2019 (exact dose, injection site, and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK) lot number N028091, expiration date: 10-MAR-2020. No adverse event was reported.
Red, swollen, hard, painful, spreading to entire upper arm, and down to elbow by the next day.
Patient received vaccination at pharmacy and then went to office in back of store to work. received call from back about 1 hour later stated patient was feeling unusual.  Went to back of store and checked patient. Patients blood pressure was elevated at 180/100. Patient temperature was normal. Discussed with patient and she decided that she would like to go to clinic to be checked
Patient hospitalized with Covid symptoms after receiving Covid vaccination.  Patient experienced respiratory distress, tachypnea, lethargy, and seizure like activity.
None at the time of vaccination, will contact parents of patient to follow up. PCP advised no cause of concern at the moment. Per PCP will advise parents to look out for high fever and to contact clinic with any concerns, mild fever is common when vaccines are administered.
I have had since then sleeping disturbances which means I woke several times in the night; I have had since then sleeping disturbances which means I woke several times in the night; This is a spontaneous report from a non-contactable physician who reported for themselves. A patient of unspecified age and unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced "I have had since then sleeping disturbances which means I woke several times in the night" on an unspecified date. The patient called and stated that they were a family doctor and had a question about the COVID-19 vaccine. The patient reported that they "got this vaccine about a week ago and I have had since then sleeping disturbances which means I woke several times in the night. The question is if the company has experienced any complaints for it." The patient was informed about the Pfizer Medical Information department and as department was closed the telephone number was provided. The clinical outcome of the event "I have had since then sleeping disturbances which means I woke several times in the night" was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
burning in her throat "like acid reflux"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Down Syndrome" (unspecified if ongoing); "allergic to sulfa" (unspecified if ongoing); "penicillin drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergic amoxicillin". The following information was reported: THROAT IRRITATION (non-serious), outcome "unknown", described as "burning in her throat "like acid reflux"".  Additional information included: At the time of report, reporter wanted to know if patient can safely get the second dose of the vaccine, also reported that, the patient is allergic to 'a lot of medications'. Reporter spoke with an agent who said it was okay for the patient to take the Covid vaccine but additionally would like to re-confirm the answer.  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-2021349175 different patient, same drug and event
inappropriate schedule of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032821A and 006M20A) for COVID-19 immunisation.     No Medical history information was reported.  Concomitant products included PANTOPRAZOLE, TIMOLOL, GLYCERYL TRINITRATE (NITROSTAT), AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), IPRATROPIUM, CLOPIDOGREL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, DICLOFENAC, OXYCODONE, DIAZEPAM, GABAPENTIN, METAXALONE and METOPROLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking Astelin nasal spray as concomitant medication.   This case was linked to MOD-2021-400060 (Patient Link).
Two days after the 2nd Pfizer vaccine, Sunday May23rd,  I woke up with a slight sore throat. I didn?t make much of it because I thought it was maybe my sinuses dripping more than usual. However, when I woke up Monday, the sore throat was evident and very bothering some. Throughout the day I experienced cold/flu symptoms like tiredness & coughing. I couldn?t function normal so I had to take DayQuil. At night in order to go to sleep I had to take NyQuil.  Tuesday morning I woke up feeling worse, my nose was very congested, the sore throat persisted and  my voice was changing. Very tired. I still did not have a fever, muscle aches nor chills. Although I did have a congested nose, I did not lose the sense of smell & taste.  Today, Wednesday I lost my voice so I?m writing this.  I haven?t had a cold in 2 years nor o have been exposed to people or places to catch COVID 19 so I?m almost positive these are side effects and symptoms from the Pfizer second vaccine.  These symptoms needs to be brought out to the light. It is very unfair to feel like one is alone on this one. Fortunately, thanks to blogs  I was able to read other bloggers who are experiencing the same symptoms, especially the SORE THROAT.
got first shot, still had an outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of shingles vaccine and experienced shingles outbreak few months later. The patient was hopeful that after second dose it would never happen. Consent to follow up was not possible as no contact details were available.
Influenza Vaccine 10/12/99 pt started itching that evening, noticed rash 10/13/99 (evening) with itching spreading.
Shingles on my back, had the Shingles shot's/Suspected vaccination failure; Shingles on my back, had the Shingles shot's; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-APR-2022 Reporter's comment: This case was received from consumer via interactive digital media. The patient self-reported this case. After receiving Shingles shot, the patient just getting over shingles on his/her back and this was second time for him/her.  The patient asked that what was up with that. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pt reported redness, pain, swelling at left deltoid injection site less than 12 hours after receiving immunization. Pt performed self care at home with TYLENOL, rest, ice and BENADRYL. No visit to ER or Urgent Care. Reported Sxs to us 2 mos after receiving.
Post Herpetic Neuralgia episode; Following my third Pfizer Covid vaccine, I have experienced increasing episodes. Three in the past 3 days; Third Pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 84-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Oct2021 09:30 (Lot number: FF2593) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: extreme case of shingles to left eye, and nerves surrounding eye 15 years ago; "squamous cell lesion" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: EL9262, Location of injection: Arm Left), administration date: 02Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot Number: EL8982, Location of injection: Arm Left), administration date: 22Jan2021, for Covid-19 Immunization; Flu zone hd (other vaccine 4 weeks product: Flu zone HD, date: 01Oct2021, dose number: 1, vaccine location: left arm), administration date: 01Oct2021. The following information was reported: IMMUNISATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "Third Pfizer Covid vaccine"; POST HERPETIC NEURALGIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Post Herpetic Neuralgia episode"; CONDITION AGGRAVATED (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Following my third Pfizer Covid vaccine, I have experienced increasing episodes. Three in the past 3 days". Therapeutic measures were not taken as a result of post herpetic neuralgia, condition aggravated.  Additional information: Within a week of my third Pfizer Covid vaccine, I experienced a Post Herpetic Neuralgia episode. An extreme case of shingles to left eye, and nerves surrounding eye 15 years ago led many post herpetic neuralgia episodes for several years, gradually decreasing to 1-3 a year. Following my third Pfizer Covid vaccine, I have experienced increasing episodes. Three in the past 3 days. Have read there may be a connection. known allergies: Unknown. If covid prior vaccination: No. If covid tested post vaccination: No  No follow-up attempts are possible. No further information is expected.
Client described numbness in (L) arm followed by tingling, coldness in hands and fingers. Client then described being lightheaded. Clients pulse and BP were elevated (P=84, BP=140/100) and was diaphoretic. Client laid down and recovered after about 45 minutes.
Interchange of vaccine products; doctor said probably caused his stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02245892.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 1), for COVID-19 immunization; Moderna covid-19 vaccine (Dose: 2), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Mar2022, outcome "unknown", described as "doctor said probably caused his stroke"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, was received by the partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023, from a nurse.   Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005126, MCM-005127, MCM-005128. MCM-005136, MCM-005135, and MCM-005138 (patient's twin).   Further information is expected.