chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has been diagnosed with Covid-19; she has been diagnosed with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Statin allergy" (unspecified if ongoing); "hair loss" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], stop date: 07May2022; PITAVASTATIN, stop date: 09May2022; FISH OIL; CINNAMON; TURMERIC [CURCUMA LONGA]; COQ-10; SPIRONOLACTONE taken for alopecia; OLMESARTAN MEDOXOMIL; EZETIMIBE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has been diagnosed with Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Diagnosed with Covid-19. Therapeutic measures were taken as a result of covid-19. Additional information: caller reports that she has a medical history of pre-diabetes, hypertension, and statin allergy. Caller reports that she takes Flonase, Pitavastatin, Fish Oil, Cinnamon, Turmeric, Coq-10, Spironolactone (takes for hair loss per Caller), Olmesartan Medoxomil 40 mg, and Ezetimibe 10 mg. Caller reports that she has also had the primary series of the Pfizer Covid-19 vaccine as well as one booster dose and usually takes Advil but has switched to Tylenol. Caller reports that she has complaints of brain fog, headache and backache. Caller reports that her last dose of Flonase was on 07May2022 and was prescribed Paxlovid on 07May2022. Caller was advised by HCP to start taking the dose of Paxlovid on the evening of 07May2022 and to stop taking her Flonase. Caller reports that she stopped taking her Pitavastatin today 09May2022. Caller reports that she has also stopped taking her Fish Oil, Cinnamon, Turmeric, and Coq-10. Caller reports that her HCP told her she can continue to take her Pitavastatin. Caller reports that she has taken 2.5 days worth of doses for Paxlovid. Caller was asking if she has to wait 90 days to get the fourth booster dose since she has been diagnosed with Covid-19.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
delayed inflammatory reaction/still suffering from the inflammatory reaction in my face, it is 11 months later; Pfizer Biv vaccine/Dose Number: 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 1, single (Lot number: GJ6665) at the age of 59 years, in left arm for covid-19 immunisation; hyaluronic acid (HYALURONIC ACID), (Batch/Lot number: unknown) at unk (cosmetic filler). The patient didn't receive bnt162b2 (BNT162B2). The patient's relevant medical history included: "breast cancer", start date: 2015 (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: FISH OIL; VITAMIN D NOS. Past drug history included: Oxycodone, reaction(s): "Known allergies: swelling from oxycodone"; Oxycodone, reaction(s): "Known allergies: swelling from oxycodone". The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 17Oct2022, outcome "unknown", described as "Pfizer Biv vaccine/Dose Number: 1"; INFLAMMATION (medically significant) with onset 15Feb2023, outcome "not recovered", described as "delayed inflammatory reaction/still suffering from the inflammatory reaction in my face, it is 11 months later". The event "delayed inflammatory reaction/still suffering from the inflammatory reaction in my face, it is 11 months later" required physician office visit. The action taken for hyaluronic acid was unknown. Therapeutic measures were taken as a result of inflammation with off label use of lisinopril and Hylenex to dissolve.  Additional information: She had cosmetic filler containing hyaluronic acid four days after the bivalent (biv) vaccine and experienced delayed inflammatory reaction. She was still suffering from the inflammatory reaction in her face, it is 11 months later.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
History of bleeding at injection site followed by hematoma and pain and tenderness. Hematoma resolved but mild tenderness and pain persisted at deltoid muscle at hematoma on left arm.
1st Dose of Heplisav-B, 2nd Dose Received Engerix-B; Initial Report Received on 09-Jun-2022  An office manager at a doctor's office  reported that a 44-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and Engerix-B for the second dose instead of HEPLISAV-B.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 02-May-2022, the patient received the first dose of HEPLISAV-B (Lot # 01003435280030171723, expiration date 23-Mar-2023, NDC # 43528-003-01) intramuscularly in the left deltoid.   On 09-Jun-2022, 39 days after having been vaccinated with HEPLISAV-B, the patient received Engerix-B (Lot #, expiration date, NDC #, and route unknown) in the left deltoid as the second dose instead of HEPLISAV-B. The reporter denied that the patient had any adverse events.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
minor sore arm; Could barely get out of bed; Was wiped out; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor sore arm), ASTHENIA (Could barely get out of bed) and FATIGUE (Was wiped out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A, 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2020, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced PAIN IN EXTREMITY (minor sore arm), ASTHENIA (Could barely get out of bed) and FATIGUE (Was wiped out). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, PAIN IN EXTREMITY (minor sore arm), ASTHENIA (Could barely get out of bed) and FATIGUE (Was wiped out) had resolved.            No concomitant medications were reported   This case was linked to MOD-2021-308014, MOD-2021-307983.
Janssen CCOVID-19 Vaccine EUA 4/9/21:  metallic taste in mouth when eating/drinking; nauseous; mild headache; fatigue; Overnight - leg cramping, coughing, heaviness in chest. 4/10/21:  fever (high of 101.5 most of day); chills; mild headache; severe fatigue; muscle cramping; dizziness; difficulty focusing & remembering. 4/11/21:  fever (high of 100.3 in am only); severe fatigue;  extreme pain in lymph nodes in left armpit (difficulty moving arm); pain behind right eye (began in evening); difficulty focusing & remembering; random short term muscle cramping
Information has been received from a certified medical assistant concerning a 21 year old female patient with anemia and a history of wrist fracture who on 19-MAR-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL vaccine (yeast) (Lot reported as 656051/0244U, "0367U", 658282/0929U). Concomitant therapy included desloratadine (CLARINEX) and oral hormonal contraceptives (unspecified). About 4 weeks after the vaccination, the patient experienced fatigue and bilateral numbness in her upper arms. Unspecified medical attention was sought. It was reported that the patient has received cyanocobalamin (VITAMIN B-12) injections for pre-existing anemia, that seem to have improved the symptoms. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
3/23/2021 became ill "cold symptoms" 3/27/2021 tested positive for covid, POC Antigen testing 04/03/2021 returned to work
Patient was standing at the checkout counter and stated "I don't feel well" and fainted. Front desk called for help, of which Dr  and the office manager were the first to get to patient and her mother followed by myself. Patient came to and asked what happen. We informed her that she fainted. We allowed for her to lay there for a minute before taking her to an exam room where she was watched for the next 10-15 minutes to make sure she would be ok. Pt was provided juice and a snack, we also monitored her blood pressure and pulse until she felt ok to sit up by herself. After pt stated she was ok, we checked her blood pressure again and allowed for her to walk around the room a little before allowing her to leave the building.
4 days after receiving my first dose of the Pfizer vaccine I found 2 lumps directly above my collarbone on my right side; They are sore to the touch like a bruise but nothing painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), ( Age at vaccination : 24) administered in arm right, administration date 23Apr2021 13:30 (Lot number: ER8736) at the age of 24 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Apr2021 13:00, outcome "unknown", described as "4 days after receiving my first dose of the Pfizer vaccine I found 2 lumps directly above my collarbone on my right side"; LYMPH NODE PAIN (non-serious) with onset 28Apr2021 13:00, outcome "unknown", described as "They are sore to the touch like a bruise but nothing painful". The events "4 days after receiving my first dose of the pfizer vaccine i found 2 lumps directly above my collarbone on my right side" and "they are sore to the touch like a bruise but nothing painful" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient was not diagnosed with Covid-19 Prior to vaccination. The patient not been tested for Covid-19 Since the vaccination. 4 days after receiving my first dose of the Pfizer vaccine I found 2 lumps directly above my collarbone on my right side. I assume they are swollen lymph nodes. I am going to urgent care tomorrow to check it out since it has been two days since I have found them and they are not going away. They are sore to the touch like a bruise but nothing painful. The size of the lumps go down when the patient takes ibuprofen but go back to the same size when it wears off. No Prolonged Hospitalization was noted.  No follow-up attempts are possible. No further information is expected.
tested positive for Covid last Sunday; tested positive for Covid last Sunday; Hot and Cold; Hot and Cold; nauseated/Nausea; fever; chills; headache; tired; feeling bad; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EP6955), on an unspecified route of administration on Arm Left on 19Mar2021 at 11:00 as single dose for COVID-19 immunisation. No additional vaccines were administered on the same date. The patient had a medical history included ongoing asthma (last time she had asthma was one month ago. Caller doesn't remember when she was first diagnosed by a doctor). The patient's concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); both are at three times a day (takes it every 8 hours). The patient was not received any vaccinations within 4 weeks. It was reported that, Patient felts tired after the vaccine. Caller states her first dose was 19Mar2021 and the next day 20Mar2021, she was tired and had a headache. Caller states she has chills on 27Mar2021 for two days only. Caller verifies it was chills she was experiencing, states she was hot and cold on 27Mar2021, unsure of what the word is in English for that. Tired and headache no more after the vaccine. Caller states nausea stopped around 03Apr2021 or 04Apr2021. Caller states she waited for her test to come back, her symptoms were bad on 27Mar2021, so she waited and stayed in her house. Caller states she tested positive for COVID, last Sunday, she waited for a long time for the test to come back. Caller verifies the date she was tested for COVID was 04Apr2021 and she found out the same day she was positive. Patent second dose will be scheduled tomorrow (09Apr2021). Caller states she would like to know if she can take the vaccine tomorrow or if she needs to wait. The patient was not visited to emergency room. Caller states she went to her physician's office after her first dose of the vaccine. Caller states she visited her family doctor because she was feeling bad by a telephone appointment yesterday with her. Caller states her doctor said she needed her weight, and she can take Tylenol. The outcome of the event tested positive for Covid last Sunday was reported as recovering, fever, chills, Hot and Cold was recovered on 28Mar2021, headache was recovered on 04Apr2021, tired was recovered on 05Apr2021, nausea was recovered on Apr2021, whereas outcome for feeling bad was unknown.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & exp swelling, redness & bruising @ inject site; 15OCT93 exp soreness running down rt arm, discoloration @ inject site & warmth & soreness @ inject site; presented to MD w/nausea & 8mm x 7mm knot @ the inject site;
Experiencing pain in my left arm around the area of the vaccine. It hurts when I turn over in bed at nights. My left arm hurts when I put clothes on. My husband has helped me many times getting  dressed. My arm hurts to raise it.  Pain is worse at night and interrupts my sleep.
A physician reported that a 6 month old female, with a history of allergic colitis, received her third dose of Prevnar, ActHIB (Aventis Pasteur SA), and Infanrix (SKB) vaccines on 06/12/01. On 06/14/2001, the infant developed blood in her stool. The reporter described this as allergic colitis. The infant was "symptoms free after changes in her and the mother's diet (breastfeeding). Info regarding this event has been forwarded to Aventis Pasteur and SKB, manufacturers of the concomitant vaccines.
Severe increase in breathing difficulty, I had to resort to O2 use constantly.Without the O2 my  Pulseox was reading an average of 87 with no energy spent and would drop into the low 80s from just walking.  Normal range in the 90s. I also was unable to sleep more than two hours at night. I could not lay down without a buildup of mucous which would choke me, I had to use my rescue inhaler and I was coughing excessively .  Also had body aches. This lasted just over two weeks.
Patient developed an abscess in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS ORAL (Patient developed an abscess in her mouth) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABSCESS ORAL (Patient developed an abscess in her mouth). At the time of the report, ABSCESS ORAL (Patient developed an abscess in her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Patient had syncope within 15 minutes following vaccine. Loss of consciousness <15 seconds, recovered quickly.
Information has been received from a licensed practical nurse (LPN) concerning a 12 month old male who on 19-SEP-2007 was inadvertently vaccinated with Zostavax (Oka/Merck) (Lot #654604/1406F) instead of Varivax (Oka/Merck) (MSD).  The reporter noted that it was not product confusion but human error.  No adverse reaction was noted.  Follow-up information was received on 28-SEP-2007 via a phone call.  The LPN stated that Zostavax (Oka/Merck) and Varivax (Oka/Merck) (MSD) vaccines had been side by side in the refrigerator.  Since the incident, they have been separated and placed in different colored bags.  The patient was last seen on 26-SEP-2007 and was fine.  Additional information has been requested.
This spontaneous report as received from a nurse practitioner, who is also the mother of the patient, via a company representative refers to a 4 month old male patient. The patient's current conditions or medical history were not reported. On 24-APR-2013, the patient was vaccinated with the first dose of Oral ROTATEQ vial 1 dose (route, Lot number and expiration date were not reported) the reporter stated that the first dose was given late to the patient. On 24-APR-2014, the reporter stated that the patient had abdominal cramping. Was cringing and holding his legs and very cranky for the rest of the day but it was unknown if the symptoms still went into the next day. Also had excessive spit up multiple times and diarrhea multiple times, and both symptoms into the next day. The reporter stated that she completely breast feed her son and he had never had had any problems. The nurse decided not to continue with Oral ROTATEQ series and her son only received the first dose. Therapy with Oral ROTATEQ was discontinued and not reintroduced. After stopping therapy, all events improved. On an unspecified date, the patient recovered from the events. The patient did not sought for medical attention and did not receive treatment for the events. No lab diagnostics were performed. Additional information has been requested.
The adverse event is that the patient was vaccinated 3 months before he turned 18 years old.
Chills; headache; body ache; lack of appetite; warm eyes; sweating.
Hot, swelling rash at injection site; extended down arm. Pt went to see his PCP & was prescribed cephalexin.
Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who received first dose of  vaccine PENTACEL lot number not reported via intramuscular route in the left thigh on 11-Dec-2018. This case involves vaccine MENACTRA, IPOL, DAPTACEL, ADACEL, ACT-HIB, FLUZONE QUADRIVALENT and while treated with TUBERSOL and HAVRIX. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; HEPATITIS B VACCINE for Immunisation; and ROTATEQ for Immunisation. It was a case of actual medication error due to Incorrect product storage. It was reported that their frig went out and they have products: PENTACEL, FLUZONE QUAD 0.25 ml and 0.5 ml and FLUZONE High-Dose, ACTHIB, ENGERIX, ADACEL, DAPTACEL, IPOL(unopened), TUBERSOL (unopened), MENACTRA, HAVRIX out of range but not sure of how long the time was yesterday the reading was 12 degrees C and the frig was not checked on Saturday or Sunday and this AM it was reading above 15 degrees C but not sure how much above 15 degrees C. States they are concerned because a 2 month old received a vaccine today and it felt warm. It was unknown if any adverse event was occurred. 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 and Module VI of the 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. Documents held by sender: none.
Fever 101-103 (weekend). Pain/swelling left anterior thigh (site of injection).
Heart palpitations every few minutes for 10 hours straight.  Eventually fell asleep and woke to occasional sharp pains or tightness in chest.  Blood pressure was normal the whole time.  3 days later and still getting occasional fluttering.
I had a little spasticity in my airways on the night of 01/16/2015. Next morning started having sore throat and minor coughing. This morning at 4:30 am my airways was so tight and had serious trouble breathing, Started using my rescue inhalers. I prepared myself to call 911 in my breathing did start to stabilize.
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 61-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. On 30th August 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced allergic reaction, injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the allergic reaction, injection site lump, injection site warmth, injection site swelling, fever, headache, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the physician. The patient received SHINGRIX vaccine in left arm. The reporter had a consumer that came into her pharmacy on 13th October 2018 to report that after receiving the SHINGRIX vaccine, the injection site became swollen, hot, red, and painful. The patient had a large red lump at the injection site. The patient's physician told her it was an allergic reaction and advised her not to get the 2nd dose of SHINGRIX vaccine. All symptoms lasted for approximately two weeks and then resolved. The reporter was unable to provide additional details. This case is linked with case US2018188583, reported by the same reporter
Narrative: COVID infection following COVID vaccine series 03/08, Pfizer, dose #1 03/27, Pfizer, dose #2 08/04 pt cc: cough, rhinorrhea, fatigue exposure; unknown 08/06 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: B.1.617.2 08/12 SARS-COV-2 CLAUDE results: 21A Delta clinically resolved
Patient described having a rash and then a bruise running down her arm starting two days following the injection. The actual injection site was not affected. The bruising is almost resolved 4 days later.
The patient was given a vaccine that was flagged by the health department as nonviable due to a refrigerator excursion.
Experienced 2 Seizures.  Landed in hospital via an ambulance.  After an EEG, CT scan, & MRI there is no explanation for the seizures.