chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to pharmacy with guardian for 3rd dose of Gardasil 9. Patient has no history of adverse reaction to previous 2 doses or influenza vaccine. Guardian contacted pharmacy approximately 5 hours post administration because patient was complaining of severe headache, chills, nausea, chest pressure, weakness, shortness of breath, and feeling "throat was closing." Guardian was advised to call 911 or go to nearest emergency room. Per guardian, patient was seeing at PCP office then transported to emergency room via EMS. Per guardian, patient is now feeling better and waiting covid-19 results at home.
Swollen armpit on left arm.  The shot was given into the left arm; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old adult non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732); via an unspecified route of administration in the left arm on 25Mar2021 at 14:45 (at the age 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date received within 2 weeks of vaccination. The patient was allergic to shellfish, cats and dogs. The patient had not received any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 00:00, the patient experienced swollen armpit on left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of swollen armpit on left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history and concurrent conditions were not informed. Concomitant therapies were not informed. On an unknown dates, from 01-JUL-2016 through 02-OCT-2016, the patients were administered improperly stored doses of PNEUMOVAX 23 lot # L017406, expiration date 26-FEB-2017, (dosages and therapy routes were not provided), using sterile diluent/vaccines (unknown dosage, lot M013638 expiration date: 19-NOV-2018 and M017521 expiration date: 12-OCT-2018). No adverse effects were reported. Not product quality complaint (PQC) was involved. The minimum temperature reported was of 0.09 degrees Celsius. No previous temperature excursions or digital data logger were involved. There was no a previous temperature excursion or call because of a data logger. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse via a company representative refers to an 18 year old female patient. On unknown date, the patient was vaccinated with the 1st, 2nd and 3rd doses of GARDASIL (route, lot number and expiration date not reported) and on 26-MAR-2015, the patient was inadvertently administered a fourth dose. No adverse effects reported. Additional information has been requested.
3 to 4 hrs. after injection (Hep A). Pt. became very irritable, lethargic, lost bladder control and stooling. Pt. was afebrile during this time and when seen at office at 8/8/17.
30 year old female requesting MMR vaccine-on assessment patient filled out paperwork assessment-noted not pregnant-Ask whether pregnant-patient said no. Came in stating she was pregnant when she received MMR vaccine.
she was a lactating; she was a lactating; Have some side effects last night from Covid Vaccine, got hives right above my breast; she has really bad Asthma/because of that she has "shortness of breath"; Felt like itchy like tingling on my lip; Felt like itchy like tingling on my lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (lot#: EK5730, expiration date: 31Mar2021), via an unspecified route of administration at arm left, on 02Jan2021 04:00, at single dose, for COVID-19 immunization, and salbutamol (ALBUTEROL) via an unspecified route of administration, from an unspecified date, at unknown dose, for asthma. Medical history included ongoing asthma, and ongoing very unslept person, and she was a lactating for she has a baby about year like 13 months ago (2019) so she is still producing milk. Concomitant medication not provided. The patient thought she has some side effects last night from her Covid Vaccine, so she got it yesterday around 4 O'clock and around 10, 10:30 she got hives on her chest, right above her breast, and about an hour after she got the vaccine, she thought it was just her asthma, so she has really bad Asthma, her Asthma kept like, she kept Asthma and because of that she has "shortness of breath" (not clarified), so she was just taking her Inhaler (unspecified medication) but then like last night wherever after that her "bedtime" (not clarified) she got hives on her chest and it felt like itchy like tingling on her lip, she was very unslept person so she just took some Benadryl (treatment) today she woke up fine, she feel fine but she was just thinking it would be okay to take her second dosage (Covid vaccine). When probed if visited to any physician office/ emergency Room for the treatment, consumer stated she just at home, she just took Benadryl. The action taken in response to the events for salbutamol was unknown. The outcome of the events was recovered.
This spontaneous report as received from a Nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot number, expiration date, dose and route unknown) for prophylaxis. No adverse effects reported. The vaccine was exposed to 47 Fahrenheit (F) to 77 F (47.5F) for 888 hours. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010403: US-009507513-1708USA010320: US-009507513-1708USA010400: US-009507513-1708USA010401:
This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the fourth of six reports. The child (age and gender not specified) received a dose of PREVNAR 13 on an unspecified date. On an unspecified date, the child developed large, raised, dark red, swelling, about 4 inches diameter in size and a fever. The child came back to the office after five to six days after the vaccination. The outcome was unknown. Follow-up (03Aug2011): Follow-up attempts completed. No further information expected.
Fever; chills; muscle aches; swelling of lymph nodes under arm; headache.
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional by phone. This case involves a 9 months old female patient (reported as 9 months and 30 days) who experienced all over body rash while she received a dose of ADACEL instead of PREVENAR 13. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 04-Feb-2019, the patient received a 0.5 single dose of ADACEL (batch number: C5566AA and expiry date: 13-Feb-2021) via intramuscular route in the left thigh. The ADACEL was in a pre-filled syringe. On an unspecified date, the patient developed a non-serious all over body rash (rash generalised), following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that patient was not supposed to receive ADACEL at that time. The patient was supposed to have received PREVNAR 13. No lab data was reported. Final diagnosis was all over body rash. It was not reported if the patient received a corrective treatment. The outcome of event all over body rash was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
A half hour after I got the shot my lips went numb (like I had a shot of Novocaine at the dentist). Then about a half hour after that, the tip of my tongue started tingling. Then a little bit after that my throat got a little tiny bit tight and dry.  Then by 2:00 in the afternoon all the symptoms disappeared. Then the next day, I felt just a little bit nauseous. Then the next day the numb lips and tingling tongue returned, except that only the left side of my lips felt numb, and only the left front quadrant of my tongue was tingling.the right side of my lips were fine and the right side of my tongue was fine. Today is April 2nd, and I still feel the tingling on the left side of the front of my tongue. That is constant. The numbness in my lips has faded, but it's still there.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration, on 05JAN2015. The patient's medical history and concomitant medications were not reported. The patient experienced injectable site is red and hot to the touch on 10JAN2015. The outcome of experienced injectable site is red and hot to the touch was unknown. Follow-up (19FEB2015): Follow-up attempts completed. No further information expected.
Rebound COVID infection with positive COVID at home test 30Sep2023; Rebound COVID infection with positive COVID at home test 30Sep2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2023, outcome "not recovered" and all described as "Rebound COVID infection with positive COVID at home test 30Sep2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2023) Positive, notes: Rebound COVID infection with positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken as treatment, Treatment start date: 22Sep2023 and Treatment stop date: 27Sep2023   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a health professional concerning a 24 year old female patient with environmental allergy and migraine syndrome who in November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and allergenic extract. In November 2006, the patient developed episodes of headache and dizziness after receiving the first injection. The episodes lasted 10 minutes and reoccurred 1-2 times per week for unknown number of weeks. In December 2006, the patient was vaccinated with the second dose of Gardasil and then she experienced severe dizziness, nausea, vomiting lasting one week. Since the end of December 2006, the patient had experienced episodes of intermittent imbalance with increasing frequency. The patient had medical evaluation with blood studies, computed axial tomography (CT) scan and magnetic resonance imaging (MRI) of brain. Results of the testing was unknown. The patient has not recovered. Additional information has been requested.
L deltoid pain since influenza vaccine. C/o pain with shoulder ROM. Pain has improved some but has not resolved. Symptoms started immediately post vaccination.
Patient seen by me on 9-27-13 at 9:25 am due to multiple episodes of seizures (at least 10 x). Each episode 20-30 sec of duration. Treated with KEPPRA.
Fever to 100.8.  Some chills, some body aches.  No treatment.   By evening of March 10th, fever subsided.
Left-sided facial numbness; Left-sided headache; Left arm ache; Shoulder ache; This is a spontaneous report received from a contactable consumer, the patient. An elderly female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unknown route of administration in the left arm on 17Mar2021 at 13:00 hours as a single dose for COVID-19 immunisation. The Medical history was not reported. Prior to 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 4 weeks prior to the COVID vaccine. Concomitant medications included calcium supplement (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN). The patient received these medications within 2 weeks of vaccination and exact therapy dates for these medications were not reported. On 17Mar2021 at 15:30 hours, after receiving the first dose of vaccine in her left upper arm, the patient felt left-sided facial numbness as if patient had a dental Novocaine injection. In addition, the patient had left-sided headache, left arm and shoulder ache. The clinical outcome of the events left-sided facial numbness, left-sided headache, left arm ache and shoulder ache was not resolved.   No follow-up attempts are possible. No further information is expected.
Flu like symptoms fever 101.7, tired yeah ache, body ache. Lasted 24 hours. Reduced fever with ibuprofen
Two days after receiving dose one of the vaccine she erupted in hives all over her body.  We sought care from her primary care physician at that time.  The hives persisted throughout the following weeks and worsened significantly after her third dose of the vaccine.  At that time we also sought care from her pediatric allergy specialist.  The consensus amongst her providers was that she was having a hives immune response to the vaccine, NOT an allergic response and that she was not in danger at any point as a result of receiving this vaccine.  Her daily allergy medication dosage was increased, at which point the hives resolved and have not returned.
Injection administered at 7:39 am. Immediate sense of relaxation during post injection. 2-3 hours later experienced some lightheadedness and tiredness, by 3pm experienced chest tightness and burning, difficulty breathing, coughing, fatigue. Used my nebulizer  every 4 hrs. Used rescue inhaler as needed Ventolin symptoms improved. 1/24/21 symptoms improved. Experienced some coughing and shortness of breath not as significant as day of vaccine. Recovery continues.
Patient presented to doctor's office with redness and swelling of left arm. Diagnosed as cellulitis, and prescribed cephalexin 500mg QID for 7 days.
Lightheaded (scared of needles). BP 154/95 (pulse 88), 139/87 (pulse 93), O2 sat 100%. Given juice and crackers.
In bed for 2 days; Feel "prickly"; heart is racing; Freezing cold; Severe fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED ACTIVITY (In bed for 2 days), PARAESTHESIA (Feel "prickly"), PALPITATIONS (heart is racing), NASOPHARYNGITIS (Freezing cold) and FATIGUE (Severe fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED ACTIVITY (In bed for 2 days), PARAESTHESIA (Feel "prickly"), PALPITATIONS (heart is racing), NASOPHARYNGITIS (Freezing cold), FATIGUE (Severe fatigue) and PYREXIA (Fever). At the time of the report, DECREASED ACTIVITY (In bed for 2 days), PARAESTHESIA (Feel "prickly"), PALPITATIONS (heart is racing), NASOPHARYNGITIS (Freezing cold), FATIGUE (Severe fatigue) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications was reported.  Treatment information was not provided.
on 20 days visit (3 yrs later) mom state p/pt recvd last shot had t105 & was seen by MD 1 hr later who felt had rxn to shot;
Low grade temperature.  Fatigue, weak. Joint pain. Arm felt tight and painful. Really bad headache.
Patient called clinic this AM, patient had received pneumo. vac. right del. C/O upper right arm swelling, red and tender since getting pneumo. vac. here at clinic day before yesterday (12-20-11). Patient was advised to come to clinic for evaluation of injection site. From outer aspect of right del. to near elbow, slight swelling and red/pink in color. Per ARNP patient needs to start BENADRYL OTC, every 4-6 hours prn. also 2cc dexamethasone. Given IM left glu.tolerated well without complaint. (lot # 6101807, exp: 10/12) Advised to call clinic if no improvement or symptoms worsen or ER of after hours. Advised not to drive when taking BENADRYL. Patient voiced understanding.
Headache, Myalgia, Diarrhea, sore left arm, fatigue, Narrative:
body aches; arm pain/injection site pain; got the second dose early, about 46 days after dose 1; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 15th November 2021 and experienced arm pain and body aches, refer case US2022AMR002316).   On 31st December 2021, the patient received the 2nd dose of Shingrix. On 31st December 2021, less than a day after receiving Shingrix, the patient experienced general body pain, pain in arm and drug dose administration interval too short. Rechallenge with Shingrix was positive. On 3rd January 2022, the outcome of the general body pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter called in to inquire what the timing was of the Shingrix second dose. Patient inadvertently got the second dose early, about 46 days after dose 1, which led to shortening of vaccination schedule. The reporter was provided dose schedule per package insert (PI) and medical advise disclaimer. The reporter wanted to know if there was any information on the efficacy when taken early, advised GlaxoSmithKline do not have any data on other dosing schedules. Patient refused to provide date of birth or mailing address or physician's information. Email was provided for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR002316:same reporter
2nd dose pass 35 days; Red bumps; red bumps and was covered in hives; Left buttock extremely sore; Left hip extremely sore; itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL PAIN (Left buttock extremely sore), PRURITUS (itching), ERYTHEMA (Red bumps), URTICARIA (red bumps and was covered in hives) and PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2020, the patient experienced PRURITUS (itching). On 19-Feb-2021, the patient experienced MUSCULOSKELETAL PAIN (Left buttock extremely sore) and ARTHRALGIA (Left hip extremely sore). On 24-Feb-2021, the patient experienced ERYTHEMA (Red bumps) and URTICARIA (red bumps and was covered in hives). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL PAIN (Left buttock extremely sore), PRURITUS (itching), ERYTHEMA (Red bumps), URTICARIA (red bumps and was covered in hives) and ARTHRALGIA (Left hip extremely sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose pass 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Additional information received on 06-APR-2021and does not contain any information.
This spontaneous report as received from a healthcare professional concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-MAY-2014, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, strength, lot number and expiration date were not reported) subcutaneous route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports than an improperly stored VARIVAX (Merck), were administered on 15-MAY-2014. The reporter stated that the VARIVAX (Merck) was exposed to a temperature of 6.4F for 2 hours on 05-MAY-2014. No adverse effect reported. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609). Additional information has been requested.