chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via a company representative referring to a 56 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, once, lot# and expiration date unknown) subcutaneously. On an unknown date, the patient had bruising and a rash at the injection site after receiving ZOSTAVAX. The patient saw a physician and no treatment was given for the events. The patient had recovered from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information is not expected as the reporter did not want to be contacted.
Skin lesions; skin rash; granulomas; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Nov2022 as dose number unknown (booster), single (Lot number: Gj3277) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF8839), administration date: 08Oct2021, when the patient was 44-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: SKIN LESION (non-serious), outcome "not recovered", described as "Skin lesions"; RASH (non-serious), outcome "not recovered", described as "skin rash"; GRANULOMA (non-serious), outcome "not recovered", described as "granulomas". The events "skin lesions", "skin rash" and "granulomas" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin lesion, rash, granuloma.  Additional information: No covid prior vaccination nor tested positive post vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been not tested for COVID-19. Treatment includes medication, biopsy, lab work.
Fever; Body Ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 12 hrs after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional case details were reported as follows: The patient received her 2nd dose of Shingrix Vaccine in upper left arm the patient reported fever and body aches 12 hours after she received vaccine.  The patient reported that symptoms resolved 24 hours after the injection. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020136679:same reporter
Slight pain; Has no appetite; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight pain), DECREASED APPETITE (Has no appetite) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Slight pain), DECREASED APPETITE (Has no appetite) and PYREXIA (Fever). On 25-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Slight pain) and DECREASED APPETITE (Has no appetite) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: F/U received on 11-may-2021,Significant: Event Fever was added, Event outcome provided
1355 Called by staff for elderly woman with "chest tightness" shortly after vaccine was given.Hx BBB, Neg stress test 2 years ago. P reported she had not eaten today. No other symptoms. Medic also responded. 1401 symptom resolved without intervention. Pt refused transport and left.
WHILE STILL IN IMMUNIZATION ROOM PT STATED SHE FAINTED.  SHE WAS STANDING AT THE TIME AND SHE FELL INTO A CHAIR AND HER FATHER TRIED TO CATCH HER GRABBING HER BY THE UPPER ARMS.  REDNESS WAS VISIBLE ON HER UPPER ARMS.  FATHER WAS UNSUCCESSFUL IN CATCHING HER AND SHE HIT THE BACK OF HER HEAD ON THE DOOR KNOB BEFORE HITTING THE FLOOR.  SHE STATES SHE WAS NOT NAUSEATED OR DIZZY BUT THAT SHE SUDDENLY FAINTED. C/O BACK OF HER HEAD HURTING.  NO HEALTHCARE PERSONNEL WAS PRESENT TO WITNESS AS STEPPED OUT OF THE ROOM TO OBTAIN IMMUNIZATION RECORD PRINT-OUT FROM PRINTER.
patient received expired dose; patient received .5ml for booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 005C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient   This case was linked to MOD-2021-402877 (Patient Link).
pt recv vax & 24hrs later exp shoulder to finger pain;pain lasted 1month;pt was treated w/flexeril & darvocet N-100;pt has had several flare-ups,lasting about 1wk,since then reported noted that inj may have been given higher up in arm
The Client came in for #2 HPV. Client and mother stated that the client was having a menstrual cycle every 10 days since she received the vaccination. We went through the literature on the HPV vaccine and told her we could not find that as a side effect. But this is a new vaccine and we would report this information. We also instructed her to take her to her Dr. We did not do the #2 HPV. We told the client to talk to her Dr. before we give her the #2 dose.
Within 72 hours of receiving vax, pt developed a fever of 104F. No further info was available at the date of the report.
fatigue; feeling  out of it; achy; headache; mucousy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling  out of it"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "achy"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; MUCOSAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "mucousy".  Additional information: Advised given to the patient that she go see her HCP. Patient asked what she should do to make her feel more comfortable, again told her she needs to go see her HCP for this. Due to long hold time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT HAS A LOCAL REACTION AT INJECTION SITE OF REDNESS IN A CIRCULAR NATURE. PATIENTS BANDAID REMOVED AND CIRCULAR REDNESS GOT BETTER. PATIENT AND PATIENTS MOTHER INSTRUCTED TO GO TO EMERGENCY CLINIC IF SYMPTOMS GOT WORSE.
Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine. This hospitalization was related to birth of child
About 4 days after the vaccine,  I had extreme itching on my hands, rash under my arms and leg and  area close to my crotch. I had peeling in the area near my pubic region and the palms of my hands.
Rash - Information has been received from a consumer concerning her son who was vaccianted with one dose of varicella virus vaccine live ( site unknown).  Subsequently the patient developed a rash.  The patient sought unspecified medical treatment.
Infant pulling at ears. Ears swollen. Approx. 1/4" raised rash suddenly appeared followed by swollen eyes. Injection site induration the size of a golf ball. Pt was given Benadryl in ER with marked improvement. Rash covered whole body. Everything cleared up in 24 hours.
Report from client left arm was size of baseball, aching down to hands, burning sensation relieved with Benadryl and ice, red, blisters developing sore.
Worsening of existing light tinnitus.  Prior to COVID vaccine, had only a small, barely noticeable ringing in my ears.  Now, the ringing is accompanied by a heaviness, throbbing.  Not painful but distracting and makes me feel foggy.
Patient developed pustule on the right neck and abscess on the right arm 2 days after vaccination, not at injection site.  Patient received I& D for abscess.  The pustule on the neck is in the process of healing.
Chest pains and breathing, on going uncontrollable vomiting, insomnia, migranes, body aches, chronic fatigue, hair loss, hospitalized 86 times over the past 3 years. All tests inconclusive. Disabled in 2010 and currently on disability. Can not name all the hospitals I have been in in the space below. Just as all the Gardasil injured girls I am still being hospitalized today. I now wears a red hospital wrist band that says ALLERGY the allergy is to Gardasil.
a large red lesion near injection site that is swollen, red, and itchy.    Read that this is called COVID arm and took an overthe counter antihistamine drug.
Developed varicella after having varivax in 1997. Follow up 02/02/05: Provider does not know the the name of lot numbers for vaccine 1 or 2, nor the manufacturer for vaccine number 2.
No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 29-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317 , expiration date 22-SEP-2022 for prophylaxis (dose #, exact dose, route and anatomical location were not provided). The temperature excursion was as follows: 6 degrees Fahrenheit (F) to 14 F (8.5 degrees F) for 18 minutes and 6 degrees F to 14 degrees F (11.9 degrees F) for 1 hour. There were no previous excursions reported. No adverse events were reported.
How long do this side effects last; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group adult selected as per vaccine specification.  The reporter asked, how long do this side effects last.
pt passed out & was sick to stomach w/in 15min p/shot;BP to come back up at first;told to get DPH;
pt reports a very sore, swollen nodule in pelvis joint area;nodule appeared approx 24hr p/vax;
Feverish, muscle aches, super sensitive and painful at injection site, nausea, headache.
The child inadvertently was given Pediarix and Pentacel when Pediarix and HIB were intended therefore the child received a double dose of Dtap and IPV.  At the time of this filing the child has not experienced any signs or symptoms related to this error.
4x5 cm induration of injection site, erythematous, mildly pruritic, lasting 5+ days.
feeling faint; My throat feels a little weird; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; ER8730) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 10:15, within few minutes of receiving the vaccine the patient felt like fainting. When notified to the staff, the patient was asked to sit in another room and started to feel better in the room. It had been in 45 minutes and then the patient was back home. It was also reported that the patient had a weird feeling in the throat which was hard to describe but he generally felt ok. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No treatment was received for the adverse events. The clinical outcome of the events feeling faint and throat discomfort were recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
09/18/2022 around 8:00AM I have fever of 100.9.  I got my COVID-19 5th dose on right arm and at the same time I got my flu vaccine on the left arm. 18 Lesions on my hand and problems with  feet and swollen feet. I went to the ER they told me to the dermatologist. 2 of my toes turned purple. I couldn't even put my shoes on. Day 4 was the worst for me. I couldn't walk. My toes were extremely. The dermatologist prescribed me ointment betamethasone Dipropionate  .05% 2 times a day for 2 weeks. I have appointment with her next week Thursday.
Red, warm indurations measuring 5" in diameter later rt arm. Pt states "arm aches" began aching evening of immunization. Dr. prescribed Benadryl and Ibuprofen
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DORZOLAMIDE TIMOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on the tenth day after my initial positive test; Positive, notes: tested positive on the tenth day after my initial positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: I was feeling well about two days after starting medication with Paxlovid but a week after that I began to feel sick again and tested positive on the tenth day after my initial positive test. patient had no Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
The mother of the child wrote on the consent form that the date of birth for the child was 11/3/2008, which would make the child 12 years old and eligible to receive the vaccine.  The immunization records show the date of birth is 11/3/2010, making the child 10 years of age and not eligible to receive the vaccine.
This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (TWINRIX, Glaxosmithkline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot.  Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 29 year old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (TWINRIX, Glaxosmithkline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). On 2 October 2008, at unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning and possible irritating substance in lot AHABB128AB ( product complaint). The lot was removed from further vaccinations. On 2 October 2008, the events were resolved. The physician considered the events were related to vaccination with TWINRIX.
10-5-11 - mother called - states child's arm swollen told mom to bring child in - (L) arm swollen with some redness - warm to touch - no tenderness to touch - apply ice packs & give MOTRIN - encourage child to move arm.
Irregular bleeding and mensuration cycle just after the vaccination.; Ongoing mensuration since 3 weeks; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis from 2014. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) and hydroxychloroquine (MANUFACTURER UNKNOWN) for unknown indication from an unspecified  date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 00:00, the patient experienced irregular bleeding and mensuration cycle just after the vaccination. Ongoing mensuration since 3 weeks since the vaccine was taken and could lead to need for doctors opinion. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events irregular bleeding and mensuration cycle and ongoing mensuration since 3 weeks was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Blood sugar rise; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Blood sugar rise". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A ID was not provided by the transfer agent. Reporter stated that her and her mom and someone else had their blood sugar rise after they've had the shots each time. Clarified product as the Covid 19 vaccine and the booster.  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-202101742407 same vaccine, AE and different patient;US-PFIZER INC-202101741528 same vaccine, AE and different patient;US-PFIZER INC-202101741528 same vaccine, AE and different patient;US-PFIZER INC-202101742765 same vaccine, AE and different patient
Vaccinee rec'd vax 11SEP90 & experienced weakness, nausea & vomiting x 1 & diarrhea on 12SEP90. Returned to hlth dept on 15OCT90 c/o weakness in both knees for the entire month p/1st vax dose-2nd dose was not given.
Arm soreness; Feeling of fever for 48 hrs (but no fever); Malaise; Fatigue; Headache; Severe heart burn for 48 hrs; One episode of watery diarrhea; One episode of vomiting; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in left arm, on 23Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included being overweight, prediabetes, hyperlipidaemia and Known allergies: Statins. Concomitant medication included fish oil, ergocalciferol (VITAMIN D), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (ARED-2 VITAMINS) and finasteride. The patient experienced arm soreness, malaise, fatigue and headache, severe heart burn for 48 hrs, one episode of watery diarrhea, one episode of vomiting and feeling of fever for 48 hrs (but no fever) all on 23Dec2020 at 10:00. Treatment included unspecified antacids and proton pump inhibitors (PPI). The patient did not have COVID prior to vaccination. The patient was tested for COVID on 25Dec2020 post vaccination (nasal swab for rapid test and antibody test on 25Dec2020 which resulted to negative). The outcome of the event Feeling of fever for 48 hrs (but no fever) was recovered on 25Dec2020 at 10:00 and the patient recovered from the remaining events on an unspecified date in Dec2020.  Information on the lot/batch number has been requested.