chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heavy arm; Rash all over the body, the only place that do not have rash is the face and getting worse day after day; cannot sleep on night time and really bad; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 21Apr2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included pre thyroid and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 23Apr2021 at 00:00, the patient experienced heavy arm then rash all over the body, the only place that do not have rash is the face and getting worse day after day and cannot sleep on night time and really bad. It was reported that the patient had stopped working, because he can't handle it. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heavy arm was resolved on 26Apr2021, after the duration of 3 days whereas the clinical outcome of the events rash all over the body, the only place that do not have rash is the face and getting worse day after day and cannot sleep on night time and really bad was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt saw MD in his office on 7/20 c/o lower 2/3 of right lower leg, including the right foot, with tingling sensation and numbness since 7/15; referred to ped neurologist
PT REPORTED FEVER, DIFFICULTY CATCHING HER BREATH, ACHEY AND SORE ARM.
Appx 3 hours post-injection, developed Acute STEMI,  Proximal LAD lesion, and had aspiration thrombectomy and drug eluding stent placement.
The Hiberix vaccine administered was 1 day past its expiration date.  It expired yesterday on 10/24/2021.  No known adverse side effects at this time.
Allergic reaction / allergy on his scalp; Felt like it burned; This spontaneous case was reported by a physician and describes the occurrence of DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ISOSORBIDE, LISINOPRIL and SERTRALINE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned). At the time of the report, DERMATITIS ALLERGIC (Allergic reaction / allergy on his scalp) and SKIN BURNING SENSATION (Felt like it burned) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided
pt recvd vax; devel extreme irritability, unconsolable, high pitched cry beginning few hrs p/ 1st dtp, lasting for >3 hrs; adm to hosp for observation;
Low libido; Vertigo; dizziness; fatigue; brain fog; headaches; dull pain on left cheek; Ear pain/ Jaw Pain; Ear pain/ Jaw Pain; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 12:00 (Lot number: EW172) at the age of 24 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single, Lot number:  EP7533, Administration time12:00 PM, Vaccine location Left arm), administration date: 04Apr2021, when the patient was 24 years old, for Covid-19 Immunisation. The following information was reported: VERTIGO (non-serious) with onset 03May2021, outcome "recovered" (06Jun2021), described as "Vertigo"; DIZZINESS (non-serious) with onset 03May2021, outcome "recovered" (06Jun2021), described as "dizziness"; FATIGUE (non-serious) with onset 03May2021, outcome "recovering", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 03May2021, outcome "recovering", described as "brain fog"; HEADACHE (non-serious) with onset 03May2021, outcome "recovering", described as "headaches"; FACIAL PAIN (non-serious) with onset 03May2021, outcome "recovering", described as "dull pain on left cheek"; EAR PAIN (non-serious), PAIN IN JAW (non-serious) all with onset 01May2021, outcome "unknown" and all described as "Ear pain/ Jaw Pain"; LIBIDO DECREASED (non-serious), outcome "not recovered", described as "Low libido". The events "vertigo", "dizziness", "fatigue", "brain fog", "headaches" and "dull pain on left cheek" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, dizziness, fatigue, feeling abnormal, headache, facial pain.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pt states she has "blood infection". Visit MD and was told she indeed has infection after noticing blood "blisters" on her arm and "bumps" on her wrists.
vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Flu Seasonal QIV  (FluLaval Tetra 2021-2022 season) (batch number XF9HG, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported a patient received the flulaval vaccine after a temperature excursion.  The reporter consented to follow up.  This is 1 of 6 cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:same reporter US-GLAXOSMITHKLINE-US2022039274:same reporter US-GLAXOSMITHKLINE-US2022039275:same reporter US-GLAXOSMITHKLINE-US2022039277:same reporter
developed 2 more on face about the same size. Plus 3 hives on right leg and 2 on left leg about same size.; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself. A 61-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6204) via an unspecified route of administration, administered in left arm on 27Apr2021 (age at the time of vaccination was 61-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Allergy: Macrofid and Allergy: sulfa drugs from an unspecified date. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6203) via an unspecified route of administration, administered in left arm on 06Apr2021 (age at the time of vaccination was 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. After first dose, the patient developed 3 small raised hives 0.5 mm in size on face. Started subside right before 2nd dose. On an unspecified date in Apr2021, the patient experienced developed 2 more on face about the same size. Plus 3 hives on right leg and 2 on left leg about same size. After 2nd dose, the patient developed 2 more on face about the same size. Plus 3 hives on right leg and 2 on left leg about same size. No treatment was received for adverse event. The clinical outcome of event was Not recovered.  No follow-up attempts are needed. No further information is expected.
The Tuesday after July 4, I started getting a persistent cough that would not go and it got progressively worse , the whole thing lasted about 10 days, I had one day with a slight headache it was very mild and then I had the persistent cough, I probably had about three days of a sore throat sometimes it would be difficult to swallow, it felt like I had a lump in the back of my throat that never went away. My girlfriend who lives with me had the symptoms about a week after me.
Lump near my left collarbone same side as injection; This is a spontaneous report from a contactable consumer (patient herself). A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186, Expiration date: Unknown), via an unspecified route of administration in left arm on 14Aug2021 at 13:00 as dose 1, single (at the age of 32-years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient did not receive any other medications in two weeks of vaccination. The patient's medical history included anaemia from an unknown date and unknown if ongoing. The patient's concomitant medications none. On 17Aug2021, the patient experienced lump near her left collarbone same side as injection. The patient underwent lab tests and procedures which included U of I saliva-based RT-PCR COVID-19 tested: negative on 24Aug2021. The patient received no treatment in response to the event. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Body ache; Headache; Joint ache; Chills; Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Extreme tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Extreme tiredness). On 24-Oct-2021, MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Extreme tiredness) had resolved.            No concomitant medications were reported. No treatment  medications were reported. Patient stated that she is not immunocompromised. Patient received the 1st dose in January, the 2nd in February and the 3rd dose on 22OCT2021. Patient stated that the dose she received was 0.5 mL 100 mcg.   This case was linked to MOD-2021-268326, MOD-2021-363244 (Patient Link).
EMS was alerted to a person fallen in the parking lot- EMS found Pt face down unresponsive but breathing with a pulse- Pt was rolled to a supine position and became responsive Pt states she felt dizzy and fell- Pt was placed in wheelchair and taken to eval area- Vitals and Hx obtained. Pt within minutes is acting her normal self and requests to leave. Pt is CAOx3 now. Final evaluation shows Pt has recovered completely and is refusing anymore care or transport to the hospital. Pt was wheeled to her vehicle in a wheelchair.
1:30 PM patient c/o aggitation; between 1:30 and 3:00 PM patient reported extreem fatigue, unable to stand, swelling of eyes and face, feeling of a lump in her throat and difficulty breathing.  Family called 911 and patient was transported via ambulance to local hospital ER.
One week later I have swelling and itching at the injection site.  It's also very hot.
77 yo female presents with cough, fatigue, body aches, and vomiting. She reports that the cough started on Tuesday and has worsened. She denies soa or wheezing. She is vaccinated for COVID-19. She has had 2 episodes of nb emesis today. She thinks this was caused from taking mucinex for the cough. Fever tmax at home was 100.9.
Patient presenting to ED with pain and swelling to the right armpit area that began 5 weeks ago.  Patient states that she had received her second COVID-19 vaccine in January 2022 and had noticed an increase pain and swelling under her right armpit.  She denies any fevers.  Symptoms occurred gradually and are still present.  Symptoms are described as moderate.  No history of the same. Patient was discharged the same day with vaccine reaction, and was cautioned to return to the ED if symptoms persist.
Tuesday -> redness, warmth, swelling (erythema) with tenderness. Localized reaction. Iced that evening with symptoms resolving by Wednesday and completely by Thursday.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included anaphylactic reaction to drug (for THYROGEN injection). On 22nd August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, palmar erythema, axillary lymph nodes enlarged, injection site erythema, skin warm, hypersensation skin, injection site warmth and pain in hand. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, axillary lymph nodes enlarged and injection site warmth were not recovered/not resolved and the outcome of the palmar erythema, injection site erythema, skin warm, hypersensation skin and pain in hand were unknown. It was unknown if the reporter considered the injection site pain, palmar erythema, axillary lymph nodes enlarged, injection site erythema, skin warm, hypersensation skin, injection site warmth and pain in hand to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on left arm. The patient experienced injection site reactions that included redness, pain and it was very sensitive to even clothing sleeves that touched the injected site area. The patient was unable to sleep on the injected arm. The palm of her left hand was red and hot to the touch and that her armpit lymph nodes were swollen. She used BENADRYL and that it helped relieve the pain somewhat. The patient had declined to provide her phone number. The patient had denied permission to contact their physician.
Inability to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Inability to sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to antibiotic), Allergy (Allergy to Nickel) and Allergy (Allergy to Copper). Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). The patient was treated with MELATONIN at an unspecified dose and frequency and MELATONIN for Insomnia, at a dose of 1 dosage form. At the time of the report, INSOMNIA (Inability to sleep) outcome was unknown.            Reporter did not allow further contact
patient received second dose in Pfizer series 2 days prior to the recommended Pfizer interval of 17-21 days. she got on day 15. she is currently pregnant, but did not report any additional adverse events other than standard side effects of vaccine
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 09-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 16 and 64. The lowest recorded temperatures were of 33 and 34 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt felt weird feeling when she got the flu shot. Later she mentioned it's very painful and got blackish bruise on that area.
10 hours after injection i was dizzy with severe muscle and bone pain.  Chills. Headache. Confusion. Restlessness. Dehydration. Runny nose. Stiff neck
Pt came in for 6 month check but, is currently 8 months, pt had already received 2 rotas in the past and was behind on well check up. Pt was normal after Vaccine was given, no side effects reported
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient of unknown demography who inadvertently received the Dtap/IPV portion of PENTACEL instead of the ordered QUADRACEL (lot number not reported for both the vaccines) via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the 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 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. List of documents held by sender: none.
No other AE; multiple temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 25-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter/once administered for prophylaxis (lot #W006583, expiration date: 23-AUG-2023; strength and route of administration were not provided) following temperature excursion on 11-MAY-2022 at 5.7 F for 7 minutes (product storage error). There was no excursion prior to 11-MAY-2022. The patient had no adverse effects or other symptoms as a result of administration.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007928: US-009507513-2207USA007832: US-009507513-2207USA007867: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA007928:
redness from top of shoulder to elbow; injection site is hard as a rock; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness from top of shoulder to elbow) and INJECTION SITE INDURATION (injection site is hard as a rock) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness from top of shoulder to elbow) and INJECTION SITE INDURATION (injection site is hard as a rock). At the time of the report, ERYTHEMA (redness from top of shoulder to elbow) and INJECTION SITE INDURATION (injection site is hard as a rock) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment medications were not reported.
experienced chills, fatigue; experienced chills, fatigue; felt lousy/wasn't able to go to work because she doesn't feel well; muscle pain; she doesn't feel well; This is a spontaneous report from a Non-contactable consumer (Patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiration Date: not reported), via unspecified route on an unknown date at single dose for covid-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that the patient got first shot last Saturday and after a few hours she experienced chills, fatigue and muscle pain and yesterday she felt lousy and got chills again. This morning she wasn't able to go to work because she doesn't feel well. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient came in to report today 9/2, that she had been experiencing lasting symptoms after receiving her Moderna shot a week and a half ago. Pt reports redness and a raised area around the injection site (4 inch diameter) and some swelling of the arm. Pt sounds congested and reports feeling absolutely miserable during this time. No change in symptoms over time. Patient has been on prednisone taper (40mg, now on 30mg) for unrelated condition, but it was unable to control symptoms.  Recommended seeing regular provider since any minor discomfort should have resolved by now.
Pt c/o painful left axilla 24 hours after immunization. Pain "moved" to upper arm, then stopped on 3/9/16.
Patient reports pain the night of the injection and lump and fever, next day was dizzy, low grade fever and redness noted. patient continues to have redness and a few lumps on the arm and has been taking coricidin cold and flu and ibuprofen to help with the discomfort.