chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number L349E, expiry date unknown) for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 29th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site hives and fever. On an unknown date, the outcome of the injection site erythema, injection site hives and fever were unknown. It was unknown if the reporter considered the injection site erythema, injection site hives and fever to be related to SHINGRIX. Additional details reported as follows: The patient received a dose of SHINGRIX on the left deltoid. Within 4 hours after vaccination, the patient experienced a raised red hives, forming approximately a 2 inch ring around the injection site and a low grade fever of 99.5 degree F. The reporter was given consent for follow up.
Patient reported previous sensitivity/syncope to vaccines. Waited the required 15 minute time post vaccination and had a seat with her legs elevated, felt anxious, and fell suddenly nauseous and vomited in the immunization administration area.  Pharmacist helped clean up, offered emergency services to patient which were declined. Took some time to clean up and we provided comfort measures while she recovered. Following vomiting episode patient was ok to leave the area.
after four days, swollen site injection with puffiness and redness. Painful, sore shoulder. looked like it had a bit of cellulitis so was advised to take advil and use hot compresses. swelling dissipated in 24-48 hrs.
made us ill like we had covid; had an increase in her fibromyalgia pain; high fever; body ache; no energy; headache; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A female patient (Age: 63; Unit: Unknown) (reporter's wife) received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation. The patient's medical history included Covid-19 in Oct2020 and Covid infection turned into pneumonia in Oct2020. Concomitant medications were not reported. Caller (male, age 64 will be 65 in (birth month withheld)) stated, "his wife (female, age 63) and he received their first dose of the Pfizer vaccine on Friday and it made them ill like they had Covid. They had Covid in Oct. We had high fever, body ache, no energy and headache. There was no way he was going to take the second shot. He felt like the dickens. Everything was fine. The storm hit Friday night, lasted all day yesterday. He had the headache and weakness, low energy. He was a stage 4 lung cancer survivor. For both, the Covid infection turned into pneumonia. That shot made them feel like we got Covid like we did in Oct. His wife also had an increase in her fibromyalgia pain. He heard people who had Covid have real bad reactions after the second dose than the first. If it did not make him feel like he had Covid then he would take the second dose. It was terrible." Caller wanted information regarding efficacy of 1 dose. No PQC present. Seriousness was reported as no. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache same day 2 hours post vaccine Next day arm redness, pain, and itching
After second dose pain at injection site; chills; diarrhea; GI upset; unwell feeling; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration left arm, on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No reported allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered as at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant at vaccination time. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 on the left arm. The patient experienced after second dose, pain at injection site, chills, diarrhea, GI upset, and unwell feeling on 20Jan2021 21:00. No treatment was given for the events. Outcome of the events was unknown. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Pain in arm at site of 1st and 2nd shot. Sharp aching, inconsistent.
Discharge Provider: MD, MPH Primary Care Provider: DO Admission Date: 4/29/2022 Discharge Date: 5/1/2022   PRESENTING PROBLEM: Hypoxia Acute on chronic diastolic (congestive) heart failure (HCC) COVID-19 long hauler   HOSPITAL COURSE: Patient is a 90 y.o. female who presented with shortness of breath . Pmh chronic diastolic chf , mod pulm htn, osa, cva ( see list below) now presenting with several day history of worsening sob . Presenting with increased sob, wt gain , increased bmp from 4/1 141 ->2656 today cxr with new small bilateral pleural effusions Echo 1/22 levf 54% Hypoxia to 88% transiently now on room air . Possibly exacerbated by recent covid infection . Following admission oral lasix held and was diuresed with iv lasix . Quickly removed from supplemental oxygen. She diuresed well more than 2.5 l with subjective improvement in breathing . Electrolytes and renal function monitored and remained stable . Tested neg for influ AB, pos for covid though 3 wks prior also testing positive and this is likely residual . She was evaluated by pt/ot and felt safe to return to home with hhc that is established already. Home with spouse, resume SHVNA and Tandem365 services. On day of dc was feeling improved , tolerating oral diet , ambulating at baseline .
Extreme disabling, immobilizing arm pain on side shot was received, radiating down to hip back and abdomen on same side about 6 hours after vaccine administered.  This symptom lasted for about 48 hours.  After that symptom cleared, a bulding slightly painful soft mass protuded from the left armpit near vaccination, and remained for 5-6 days. Swelling of all lymphnodes.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 10th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:
So bright I couldn't see anything because it was so bright/ brightness bothering patients eyes; 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 78 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 12Oct2021 (Lot number: EN6198) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: Left arm), administration date: 29Jan2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Left arm, lot number EL1284), administration date: 26Feb2021, when the patient was 78 years old, for COVID-19 Immunization. The following information was reported: VISUAL BRIGHTNESS (non-serious) with onset 13Oct2021 10:30, outcome "recovered" (13Oct2021 11:30), described as "So bright I couldn't see anything because it was so bright/ brightness bothering patients eyes".  Additional information: The patient received her Pfizer BT Covid Booster dose on 12Oct2021. She came home and was fine and then the next day,13Oct2021, she had an appt with her PCP and when she went to the appt it was dark out and then she left at 10:30 and it was so bright she couldn't see anything because it was so bright. The patient stated it went away in about 60 min. The patient wanted to know had there been any other reports of brightness bothering patients eyes so it is hard for them to see after the vaccine. Response: Spoke to patient from the attached document: 20Apr2021 No information found regarding product medical question. The NDC number and expiry dates were unknown. There were no other products or investigation assessment. The patient would like to know if there was any information about what she experienced after the Pfizer COVID booster. She took the COVID booster on Tuesday. On Wednesday morning she was feeling good, and slept good. When she left her house at 730-8am it was still dark. She came out of her appointment at 1030am, and it was so bright she could not see. She literally could not see. It only happened just one time. She was glad she didn't drive because she couldn't have drove. Her appointment was at 830 am. She was just curious if this had been reported. She got the two prior vaccines with no problem. She had no side effects. Her height is 5'8"-5'9". She didn't have a prescribing doctor.  Follow-up attempts are completed. No further information is expected.
After patient received vaccine had localized reaction in left deltoid.  Redness and firm to touch.  Patient observed for additional time frame and redness lessened.  Patient released home.
incidence of arm pain (pain at the injection site); This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot numbers and expiry dates were unknown), first dose administered in right arm on 29Jan2021 and second dose administered in left arm on 19Feb2021; both via unspecified route of administration as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had incidence of arm pain (pain at the injection site) after the 1st and 2nd vaccination. The consumer asked if arm pain (right arm, where the 1st dose was administered) is an adverse event associated to the Pfizer BioNTech COVID-19 vaccine, even if it was administered several weeks ago. When she first got it (first dose), the kind of pain she experienced was like having a stroke or something, is like (feeling) out of whack, it felt like when she exercised it was strange. After receiving the 2nd COVID-19 vaccine (left arm), the pain was gone for 1.5 days. The outcome of the event was recovered on unspecified date.  No follow-up attempts are possible; information about lot numbers of both doses cannot be obtained.
Left Main/Three Vessel Coronary Artery Disease s/p CABG, procedure. Hospital admission within 6 weeks of receiving the COVID vaccine.
muscle pain; nerve pain; fingers tickling; unable to sleep; joint pain; shivering; pain in the arm; ears ringing; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On 15th May 2019, 6 hrs after receiving Shingrix, the patient experienced muscle pain, nerve pain, tingling, sleeplessness, joint pain, shivering and pain in arm. In May 2019, the patient experienced ringing in ears. On an unknown date, the outcome of the muscle pain, nerve pain, tingling, ringing in ears, sleeplessness, joint pain, shivering and pain in arm were unknown.   It was unknown if the reporter considered the muscle pain, nerve pain, tingling, ringing in ears, sleeplessness, joint pain, shivering and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The patient was repoter's wife. The patient received shingrix vaccine and after couple of hours the patient experienced Pain in the arm, 6 or 8 hours after joint pain, muscle pain shivering, nerve pain ,fingers tickleing at night unable to sleep and ears ringing  The patient asked whether ears ringing and the events reported were  common or not.
Extreme pain on administration. Pain in shoulder, now, 3 weeks later with weakness and decreased range of motion in left shoulder - shot was given in left deltoid.
I'm allergic to ingredients.; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient allergic to the ingredients of Flu shot. No other information was available.
1/2 am - light red circle surrounding varicella vaccination site. reaction was immediate. Advised provider immediately. O TX done (a) this time. (R) Arm subq.
6/11/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  facial tingling, dysphasia.   Assessment : Time of assessment 0904. Alert and oriented and anxious.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 0924. VS at 0904- BP- 149/77, 0910- BP- 179/88. P- 58, O2- 100%, 0920- BP- 156/90     Medications administered: Loratadine (Claritin) 10 mg  by mouth. Time: 0910. Administered by rn.   Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 0924.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 6/11/2021  8:30 AM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8736   NDC: 59267-1000-1          Electronically signed by RN at 6/11/2021 11:05 AM Immunization on 6/11/2021  Immunization on 6/11/2021   Detailed Report  Note shared with patient
After receiving the vaccine, my arm pain increased in pain until I could not even lift my arm. I noticed he bandaid was very high up on my arm, really at my shoulder. I took photos the next morning. It has not been a little over a month and I still have pain when I use my left arm in a certain way, such as putting my bra on and putting shirts on and off. As well, it hurts when I roll over at night. The pain intensifies at times and I?m not sure why. Some days I?m almost in tears and other days I hardly notice except when getting dressed or rolling over in bed.
Patient reported feeling dizzy Patient provided with water and seen by medical team Patient refused medical transport and signed AMA form Patient stated her symptoms resolved
Aches, fever of 100.0 at 3:15 am. Felt better Tuesday morning
Burning in throat feels similar to acid reflux but with tingling also present in throat.  Started about 36 hours post shot still continuing.   Diarrhea started 36 hours post shot still continuing.
Patient in Post Menopause for 12 years and on 3/1/2021 suffered severe vaginal bleeding and clotting that has continued for 3 + weeks, Uterine Biopsy completed 3/15/22 was negative and showed normal parameters.
Fever; Fatigue, laid down entire day; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue, laid down entire day) and ABDOMINAL PAIN UPPER (Stomach pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue, laid down entire day) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue, laid down entire day) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.            No concomitant medications reported.  The patient had a lot of stomach pain. He had to go to bathroom couple of times. He also had fever and fatigue. He laid down entire day. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
The following day Dec 30 after vaccination she felt increased heart palpitations- rapid, hard beats.  Dec 31 pt reported she felt dizzy, "almost passed out, but didn't." Her cardiologist called her due to irregular recording from the loop recorder. He told her he would continue to monitor. She reports most symptoms have resolved, but she does feel weak when up with a rapid heart beat.
Recently was with her daughter/family, which now have tested positive; This is a spontaneous report from a Pfizer-sponsored program form a contactable female consumer (Patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant was not reported. Patient stated that recently she was with her daughter/family, which now have tested positive. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient developed fever to 101 at 11:00 pm 03/12/2020 then in the morning of 03/13/2020 had fainting followed by shaking at home.  Transported to Hospital where she recovered with IV fluids and was discharge home with diagnosis of syncope and fever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm 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); "GERD" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: 01Apr2019. Past drug history included: Nickel, reaction(s): "nickel: Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) negative; (30May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Vomiting-Mild, Additional Details: Patient passed out within 30 seconds of receiving the Pfizer COVID vaccine.  She was out for about 15-20 seconds, during which time she had a couple spasms.  After that, she woke up, was aware that she had passed out, then threw up once. She waited with her mom for 30 minutes after that, but felt fine during that period.
Information has been received from a health professional concerning a 5 week old patient who was vaccinated with a dose of Rotateq. No symptoms noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a registered nurse (RN) concerning a 36-day-old female who on 02-OCT-2006 was vaccinated PO with the first dose of ROTATEQ (Lot #654392/0578F).  Concomitant vaccinations administered on that same day included the first IM dose of PEDIARIX (Lot #AC21B0590A) and the first IM dose of PREVNAR (Lot #B08642H).  Unspecified medical attention was sought and no symptoms were noted.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 15Feb2021 as dose 2, single (Lot number: EL9261), in right arm and on 29Sep2021 as dose 3 (booster) single (Lot number: 3014BA) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was received Paxlovid from 02Jul2022 to 06Jul2022. Return of symptoms after completing Paxlovid on 13Jul2022.