chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states that she is having severe pain in her upper arm in the area of the vaccine administration site. Pt states that it is almost like a cramping type feeling that lasts for a minute or two. This has been going on for 3 days now. Pt stated she wanted to go to the doctor but I advised her to wait a week and if it was still not clinically improving.
Information has been received from a health professional concerning a 28 yr old white female, with no reported medical history or allergies, who on 23Jun05, at 10:00AM, was vaccinated with a first dose in the left arm of varicella virus vaccine live (lot 648552/0113R). There was no illness at the time of vaccination and there were no reported adverse events following prior vaccination. It was reported that on 23Jun05 the pt developed an area about 3 inches in diameter at the injection site that was red, warm, hard and itchy for 4 days. The pt also had flu like symptoms, but it was noted that she had been flying at the same time. It was reported that the pt recovered. Medical attention was not sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 24Jun05, in the AM, the pt began to have flu like symptoms and her arm began to feel itchy. Then the site became warm and hard, about the size of a 50 cent coin. The symptoms lasted four days. On 22Jul05, at 8:45 AM the pt was vaccinated with a second dose in the right arm of varicella virus vaccine live (lot648297/0217R). It was noted that pt did not report adverse effects to the second dose of varicella virus vaccine live. Additional information is not expected.
Rash on inside of each arm at elbow. At injection point-cyst (pussed, than scabbed over) (noted that nurse had never seen a cyst like this one before).
Initial and follow-up information has been received from a registered nurse concerning a 41 year old female with no pertinent medical history and no known drug reactions or allergies, who on 23-SEP-2008 was vaccinated with a first dose of VARIVAX (Merck) (lot # 661334/0737X) 0.5 mL, subcutaneously into her left triceps. Concomitant vaccination included a fifth dose of ENGERIX-B (lot # AHABVB584AA) into her left thigh. On 24-SEP-2008 the patient developed an injection site reaction following vaccination with VARIVAX (Merck). The patient had a large raised oval reddened area approximately 6" long to 2" wide, and a swollen area that was 6 inches long (shaped like a cucumber). The oval was mostly below the injection site, but just at the injection site the area was hardened and warm in addition to being swollen and red. Skin area was hot to touch. The patient did not have any fever. Reactions caused a significant discomfort. No fever reported. It was also reported that there was itching at site of injection (also reported as beginning on day 4 on 26-SEP-2008). There were no labs or diagnostic studies performed. The patient sought unspecified medical attention. The patient recovered from the large raised reddened area, significant discomfort, itching at site and area hot to touch on 29-SEP-2008 (previously reported as 28-SEP-2008). The patient also recovered from all the adverse events on 29-SEP-2008. There was no illness at time of vaccination. Additional information is not expected.
Scleritis; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 301208A), via an unspecified route of administration, administered in left arm on 03Sep2021 15:30 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and has no known allergies. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. No other vaccine was given in four weeks and no other medications in two weeks. On 07Sep2021 21:45, the patient developed scleritis in her right eye. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of scleritis which included Steroid eye drops every 2 hours x 14 days. The patient underwent lab tests and procedures which included COVID test post vaccination: PCR via nasal swab on 09Sep2021 which was negative. The outcome of the event was recovering.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Scleritis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Redness, warmth and swelling 2 days post injection. Seen in ED and prescribed doxycycline and improving.
Patient has subcutaneous 1.5cm nodule with overlying blanching erythema on upper right thigh at site of previous Varicella vaccine administration (left thigh had Influenza vaccine given on same day with no adverse reaction). No tenderness to palpation. The site is slightly warm to touch. No inguinal lymph nodes palpable. Patient able to ambulate normally. No pus, drainage, puncture site, umbilication, open wound, or bleeding from the area.
swelling in chest cavity; soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in chest cavity) and VACCINATION SITE PAIN (soreness in injection arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced SWELLING (swelling in chest cavity) and VACCINATION SITE PAIN (soreness in injection arm). At the time of the report, SWELLING (swelling in chest cavity) and VACCINATION SITE PAIN (soreness in injection arm) outcome was unknown.            No concomitant medications reported.  No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Shortly after receiving vaccine the individual experienced an anaphylactoid reaction. Patient presented to the ED, received Benadryl and decadron. Patient experienced worsening full body tingling, full body shaking, and increased heart rate. Patient received IM epinephrine. symptoms resolved 10-15mins later. Patient was discharged from the ER.
having reactions to the shot; Not feeling good; Weak; headache; chills; achy muscles; rash on legs and thighs; Sore and achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Allergy to Sulfa.) and Allergic reaction to analgesics (Celebrex and Percocet).    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache), CHILLS (chills), MYALGIA (achy muscles), RASH (rash on legs and thighs) and MYALGIA (Sore and achy). At the time of the report, VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache), CHILLS (chills), MYALGIA (achy muscles), RASH (rash on legs and thighs) and MYALGIA (Sore and achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was included. Treatment medication included Tylenol..
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 13-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. Pharmacist is not sure if the expiration date of 05-OCT-2012 is of the ZOSTAVAX or diluent used in the ZOSTAVAX. No adverse events reported. No treatment information was reported. The outcome of expired drug administered and no adverse event is unknown. Expired drug administered is not related to ZOSTAVAX. Additional information has been requested.
Patient walked out of office into lobby where receptionist noticed he was pale and he reported feeling dizzy and nauseous. He was brought back into an exam room where he laid down on the table. After 10 minutes patients symptoms subsided and he walked left our office on his own.
Started On day number 12  after the vaccine thru  day number 15 ( lasted 4 days ) the injection site became painful  with a tennis ball size red area
Body chills, cold extremities and continued extreme fatigue. Also, skin rash with pustules that itch on  various parts of the body
No additional adverse events; child should have received second dose of PROQUAD; This spontaneous report was received from am office manager, referring to a 15 month old patient.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On 18-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S0239311, expiration date 04-DEC-2021, for prophylaxis (strength, route and dosage schedule not reported). On 04-AUG-2021, the patient was vaccinated with another dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHa) lot # T028297, expiration date 16-FEB-2020, for prophylaxis.    No additional adverse events reported.  Lot number S0239311 has been determined to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
her husband is having ankle replacement in 10 days; This is a spontaneous report from a Pfizer-sponsored program from a consumer (wife) reported for husband.   An elderly male patient over the age of 65 years received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE  (at unspecified age) for covid-19 immunisation.  The patient received dose one of BNT162B2 for Covid-19 immunization on unspecified date, route and lot number.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The reporter stated her husband is having ankle replacement in 10 days on an unspecified date with outcome of unknown.    The lot number for (BNT162B2), was not provided and will be requested during follow-up.
she was cut by the glass when the finger flange broke; HCP getting cut by the broken finger flange/ she was cut by the glass when the finger flange broke; which included "broken VAQTA/ a pre-filled syringe and the finger flange broke/ When she picked the VAQTA out of the tray the finger flange broke; This spontaneous report was received from a nurse, referring about herself as a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JAN-2023, after receiving a shipment of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W029899 was verified to be a valid number, expiration date: 16-MAY-2024), she went to store the product, when she picked the hepatitis a vaccine, inactivated (VAQTA) out of the tray the finger flange broke completely off (syringe issue); she was cut by the glass when the finger flange broke (skin laceration and injury associated with device), said it was "a thumb prick" and she needed to apply a band aid. The product was not administered. The reporter said she would set aside the product for retrieval.  At the time of reporting, the patient had recovered from the event.  The reporter did not provide a causal relationship between the events and the suspect vaccine.
5 d. p/ IM hep b 10 mcg injection LT deltoid developed warmth, pruritus, pain, black & blue discoloration; in ofc 1/2 x 1/2 purpura @ inj site, 6x5 cm induration @ deltoid below injection site;
DTaP was given on 05-15-07.  Mom called on 05-16-07 at 0820 to say his leg from mid thigh to knee was warm to touch and hard.  Encouraged to phone her primary care provider.  05-17-07 0945 Her Dr. said to let them know if it was worse or not better. It looked the same as yesterday.  Was warm to touch, slightly reddened, and rock hard on whole thigh to knee.  Encouraged mom to call primary care provider if she felt it wasn't improving. Child had no fever and wasn't complaining of pain.  Was using leg as normal.  05-18-07 1356 Call to Dr yesterday told her to keep watching his leg.  Mom states today it is still swollen but not reddened or warm to touch.  She feels it is improving.
Headache, CoughWheeze, swollen glands, intermittent burning sensation at injection site, fatigue Narrative:
high fever/her fever shot up; severe body aches/entire body hurt/aching in pain; barely able to move/unable to really move; stiffness in her neck; felt faint/going to faint any time; red bump at the injection site; red bump at the injection site; couldn´t move her neck; crying; she was in bed for days; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a day after receiving Meningococcal B vaccine, the patient experienced fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired were unknown.   It was unknown if the reporter considered the fever, general body pain, movements reduced, stiff neck, felt faint, injection site swelling, injection site erythema, neck rigid, crying and activities of daily living impaired to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Meningococcal B vaccine and had reaction at injection site and spent several days after the shot and crying with high fever, severe body aches, barely able to move, stiffness in her neck and felt faint ant time she tried to get up out of bed. The patient had small red bumps at injection site. The patient took the first round and by the time and got her home she was bad.  When it came time for the second round even her doctor was not ok with her taking it.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR118289:Same reporter
Received vaccine on 4/2/2021 at 4pm. Red/itchy face and neck at 5:30pm (hour an a half after vaccine).  Facial swelling : eyes, face, cheeks at 1am on 4/3/2021 (9 hours after vaccine). No difficulty breathing, swallowing.
Dizziness, vomiting, rapid heartbeat, chills, temperature 96.4
pain at injection site, then turned to red blotches, then turned into a a blister about 3 inches away from injection site.  Patient was treated with keflex and a medrol dosepack on 05/28.  patient had f/u with provider on 06/03/2021.  Patient is much improved. rash and blotchy skin went away.  only a blister is remaining
Pt recvd DTP/OPV 24APR92 & pt felt uncomfortable all day, by next AM, upper arm @ vax site was swelled up like a fist, somewhat red & warm; 25APR92 & 25APR92 noc pt itching w/small red bumps on feet;
I have been in menopause for 7 years.  After the 1st shot I noticed a return of hot flashes.  After the 2nd shot I have had them every day , now  for 6 months.
Achy body mostly felt in the bones and joints; Headache with slight brain fog; Headache with slight brain fog; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247, Expiration date: unknown) via an unspecified route of administration on left arm on 11Feb2021 at single dose for COVID-19 Immunization. Patient medical history included first dose of COVID-19 on 20Jan2021 at 11:30 AM on left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12 Feb2021 patient experienced achy body mostly felt in the bones and joints, Headache with slight brain fog, Patient did not received any treatment. Upon follow up on 24Feb2021 received in response to the mail trail sent regarding the confirmation below mentioned query (confirmation of the awareness date). The response included: the patient received second dose on 11Feb2021 and started to feel the symptoms on 12Feb2021. Relevant clinical information, product start date. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
headache/headache at temples radiating to base of skull; Chills; Fever of 100.0; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), via an unspecified route of administration on right arm on 05Feb2021 09:00 AM at single dose for Covid-19 immunisation. Patient was not pregnant. Medical history was not reported. No other vaccine was received by the patient in four weeks. Other medications in two weeks included birth control. Past drug event included neosporin allergy. 12 hours after injection on 05Feb2021 at 21:00 PM, the patient experienced headache at temples radiating to base of skull, chills, fever of 100.0. No treatment received for events. Patient didn't have Covid prior vaccination. No Covid tested was done post vaccination. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Now suffering from symptoms similar to that of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Now suffering from symptoms similar to that of COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 SUSPECTED COVID-19 (Now suffering from symptoms similar to that of COVID-19). At the time of the report, SUSPECTED COVID-19 (Now suffering from symptoms similar to that of COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient has tested COVID-19 negative for multiple times.         No Concomitant medications were reported. No Treatment details were reported.  Company Comment:- This case concerns a female patient  of unknown age with no relevant medical history reported, who experienced the unexpected event of suspected COVID 19. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The patient reported that she was suffering at the time from symptoms similar to that of COVID-19. Patient has tested COVID-19 negative for multiple times. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up document contains Non- Significant information; Sender's Comments: This case concerns a female patient  of unknown age with no relevant medical history reported, who experienced the unexpected event of suspected COVID 19. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The patient reported that she was suffering at the time from symptoms similar to that of COVID-19. Patient has tested COVID-19 negative for multiple times. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
chills; arm  hurts; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (body aches) 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-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced CHILLS (chills) and MYALGIA (body aches). At the time of the report, CHILLS (chills) and MYALGIA (body aches) had not resolved. Not Provided          No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Had 3 dose of Moderna in December of 2021 and contracted COVID-19 in May of 2022.
"Pt received vaccine at 11:57 - pt started to c/o tongue felt metallic taste and felt numb at 12:06. Pt c/o slight sweating. Pt did not eat breakfast and states this has not happened to him before. Pt denies cp, sob, tongue swelling, trouble swallowing, dizziness. Pt requesting some water. Initial vitasl 142/76   99% RA.  Hr 76. RR 20. 12:24 - pt still c/o sweating, funny taste in  Mouth.  Pt repeat vitasl 142/82 100% RA HR 85. RR 20.  Feel pt needs further evaluation. No rash, cp, sob, trouble swallowing. Pt still diaphoretic.   Note from ED: 46yoM with possible allergic reaction after Moderna vaccine. VS wnl, OP exam wnl, no signs of anaphylaxis or airway compromise. Monitored here in the ED and did well with symptom resolution. Advised on current CDC recommendations to avoid 2nd injection, as well as potential for rebound allergic reaction, with good return to ED instructions. Pt indicated understanding. No evidence of anaphylaxis or airway compromise.  Discussed rebound potential; feel home observation reasonable.  Instructed on antigen avoidence. "
area around the shot got very red and hot.; area around the shot got very red and hot; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced area around the shot got very red and hot area around the shot got very red and hot on an unspecified date. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.