chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Patient was very cold), HYPERHIDROSIS (Woke up in a pool of sweat), PAIN IN EXTREMITY (Arm is very painful) and PYREXIA (Today she feels feverish inside) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A and 939906) for COVID-19 vaccination. Concurrent medical conditions included Stomach ache and Reflux gastritis (Yesterday, the ball came back and then patient had the vaccine and it was gone). Concomitant products included OMEPRAZOLE for Stomach ache and Reflux gastritis. On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm is very painful). On 10-Nov-2021, the patient experienced PYREXIA (Today she feels feverish inside). In November 2021, the patient experienced FEELING COLD (Patient was very cold) and HYPERHIDROSIS (Woke up in a pool of sweat). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Patient was very cold), HYPERHIDROSIS (Woke up in a pool of sweat), PAIN IN EXTREMITY (Arm is very painful) and PYREXIA (Today she feels feverish inside) outcome was unknown. The pain in arm was reported as hurting more than the first dose. The patient had stomach ache, and had reflux and felt like a ball in the stomach but this was even before the first dose.On 09 Nov 2021, the ball came back and then patient had the vaccine and it was gone.During the night the patient very cold and woke up in a pool of sweat.The patient used sweater because she was very cold.This case was linked to MOD-2021-382980 (Patient Link).
Intern pharmacist vaccinated patient with Moderna vaccine that was stored outside of refridgerator for greater than 24 hours.
Left shoulder joint pain/soreness (same arm as where vaccine was given). Pain worsened over 10d period. Pain limited range of motion. No neurological deficits. No treatment initially, then when patient presented at day 10 recommended rest, ice, NSAIDs prn.
On approximately 10/01/2000 the patient experienced "breakthrough lesions on his trunk, neck and arms". He was seen in a physician's office on 10/07/2000. Follow up information reported that the patient was diagnosed with "probable Varivax reaction, candical diaper dermatitis". It was noted the patient had a few pink papules on his trunk and 2 fluid filled. Additionally the injections site was red and tender. The patient was seen again on 10/12/2000. It was reported that the "spots faded" and the patient recovered. No further information is available.
No symptoms for 11 hours, then fever of 102 F, swelling, redness (2-in. diameter), and soreness at injection site. Two ibuprofen and a night's sleep reduced the fever. Swelling, redness and soreness continued for 5 days.
Redness at injectin site, chills but no fever. Next day, increase in size at injection site, itchy. Next day injection site still firm, left pain numbness, dizziness X 1 hour-unclear if related to injection.
Employee noted deep pink flush over face, neck, chest, abdomen, upper arms.  No raised areas, non-itchy.  Denies ST, HA, throat or breathing tightness.  Lung sounds clear bilaterally.  O2 sat 98°,P-98, BP-167/92, T-99.6
Pain at the injection site/today the pain is heavy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In AUG-2023, the patient received Arexvy. In AUG-2023, 5 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at the injection site/today the pain is heavy).  The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient stated 10 days ago from reporting he received Arexvy vaccine. 5 days later he developed pain in the injection site that was getting worst day by day, today (31 August 2023) the pain was heavy. No further information was provided. The reporter consented to follow up.
Sore arm tightness and shoulder socket, numbness/ pins & needles in left arm
Patient came in and was due for 9 different vaccines. Mom declined flu, but wanted her up to date with the rest of the vaccinations. To minimize pokes, a combo-vaccination (Pediarix) was used and 6 shots were given. It was not caught when drawing up and putting into the system that there was a stand alone Hep B, a Hep B in the combo-vaccination, and that HIB was missed. The child ended up getting 2 doses of Hep B and missed getting HIB.  The mother was called and she stated that her daughter was feeling fine. That she had no local reactions. She stated that she did have a fever of 101, and fussiness the day before. The fever went away with the administration of a fever reducer. She planned to get her HIB vaccine at her next well child check up in 2 weeks.
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  syncope. Sitting in chair, fell to right hitting head on floor, patient became alert within seconds, transported via w/c to stretcher to be assessed by EMS, vitals taken, within normal limits, CBG 94, pt being sent home on concussion protocol, Fiance driving patient home and staying with her for 24 hours. Patient refused transport to hospital. Alert oriented at discharge.   Assessment : Time of assessment 0943. Alert and oriented. Paramedic on site, vitals taken Actions taken:  Vitals sign taken  VAERS form completed   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
Alopecia extreme Hair loss started at about 3 weeks after, alos skin rashes , tremors
a single vaginal blood clot,; This spontaneous case was reported by a pharmacist and describes the occurrence of MENSTRUAL DISORDER (a single vaginal blood clot,) 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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MENSTRUAL DISORDER (a single vaginal blood clot,). At the time of the report, MENSTRUAL DISORDER (a single vaginal blood clot,) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
2 hours after injection I was unable to raise my arm above the shoulder level. Severe pain when raising arm. Then 24 hours later there was a red raised area at site of injection. It was HOT to touch. 2-3" in diameter. An extremely tender painful area. Raised at least 1/2" and a solid "mass" like area.
Dizzy & Lightheaded  when walking  2-3 days so far after getting vaccinated
10 year old patient received COVID-19 bivalent booster for 12 y/o and older.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
sick for one day with his first dose of covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (sick for one day with his first dose of covid-19 vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 05-Jan-2022, the patient experienced IMMUNISATION REACTION (sick for one day with his first dose of covid-19 vaccine). In January 2022, IMMUNISATION REACTION (sick for one day with his first dose of covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient felt that SKYRIZI did not work on him as well as it should. Plaque psoriasis just cleared up a little bit but still had some and it came back stronger by the three month. He was sick for one day with his first dose of covid-19 vaccine.  No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Significant live follow up (event coding updated).
Since my first menstrual period came after I received the covid vaccine, I have been spotting and passing clots daily in between periods.
The client was given the wrong vaccine for the 2nd dose.  The client received Moderna on 8/7/2021, lot # 009C21A, then her 2nd dose she was mistakenly given Pfizer on 9/1/2021, lot # EW0167.  The client reported that later in the day about 10 hours after the vaccine, she was at dinner and started to feel "very hot /flushed, heart racing" (paraphrased), she was concerned that she was going to have a "heart attack or something" (paraphrased).  She reported that she didn't go to seek any medical attention and just went home and rested.   She notified the outreach location where she received the vaccine as she noticed that she got the wrong vaccine per her card.  The facility notifies our outreach coordinator and the client called the Health Department to give a report of the incident on 9/3/2021.  After looking into the incident, I have met with the team and discovered that protocol was not followed by the individual who provided the vaccine.  The corrective action plan has been put into place to make the necessary changes to the process to insure compliance with the standard process.
pt took vax 630PM & ate dinner 8PM; 330AM woke up w/vomiting, diarrhea & severe abdo pain; pt had another attack of diarrhea & vomiting about 8AM & then just diarrhea @ 1130AM; began to get better;
Information has been received from an approximately 76 year old female with no pertinent medical history and no drug reaction or allergies who "about 3 or 4 years ago" in approximately 2006, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapy included TRICOR, ezetimibe, TOPROL XL TABLETS and EVISTA. The patient reported that "about 4 weeks ago", on approximately 22-JUN-2010, she started with a pain in her back for 3 days, then she broke out in a rash, not knowing what it was, then she went to her doctor who diagnosed it as shingles right away. He put the patient on anti viral medication (name and manufacturer unspecified) for a week and Hydrocodone (manufacturer unspecified). Then, instead of getting better, it got worse. She did not seem to be getting any better. She went back to the doctor and he put her on Neurontin (manufacturer unspecified). She had been using the Neurontin and it helped, some. Patient also stated she had been very inactive and unable to put on her clothes, she could not eat and have lost about between 8 and 12 pounds. The second blood test did not show anything different than the first blood test. The reason she took the second blood test was because she was losing weight and the doctor ordered the test, however everything on the blood test was fine. Her whole life she "had gone down the drain", and she was not able to do anything at the moment of the report. She is normally an active person. She was in so much agony. Regular blood test work was performed twice. At the time of the report the patient was not recovered. Patient sought medical attention by a visit to the physician twice. Upon internal review had been very inactive and unable to put on her clothes, could not eat and have lost about between 8 and 12 pounds and not able to do anything were considered to be immediately disabling. Additional information has been requested.
meningitis; bad headache; I was like really dizzy; disoriented; I was like hearing voices kind of and just irritable; venous thrombosis; 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 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: FH8028) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: I am not sure I get high blood pressure once in a while. There were no concomitant medications. The following information was reported: MENINGITIS (medically significant), outcome "recovering", described as "meningitis"; HEADACHE (non-serious), outcome "recovered", described as "bad headache"; DIZZINESS (non-serious), outcome "recovering", described as "I was like really dizzy"; DISORIENTATION (non-serious), outcome "recovering", described as "disoriented"; IRRITABILITY (non-serious), outcome "recovering", described as "I was like hearing voices kind of and just irritable"; VENOUS THROMBOSIS (non-serious), outcome "recovering", described as "venous thrombosis". Therapeutic measures were not taken as a result of meningitis, headache, dizziness, disorientation, irritability, venous thrombosis. Clinical course: Patient had a "bad headache for both vaccines" and it goes away in like a day or two. After both shots, he was like really dizzy and disoriented and he was like hearing voices kind of and just irritable. No prior vaccination was taken with in four weeks.  Follow-up attempts are completed. No further information is expected.
This patient had "choking / aspiration" spell at home about 5-6 hours after immunization. She was not breathing well, turned pale with perioral cyanosis. EMS called. Infant recovered before reaching ER.
Patient presented with chest pain and was found to have pulmonary embolism 2 weeks after receiving the vaccine.  Patient without any other risk factors for DVT or pulmonary embolism
Headache; Coughing; got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FK5618) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; COUGH (non-serious), outcome "unknown", described as "Coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: They got their Covid shot on 02Dec2021 and then they were due for their second dose but then they got Covid, tested positive for Covid on 03Jan2021. When they got Covid they did had headache and coughing.  Product investigation received from product quality group on 20Jan2022 for COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 PEDIATRIC with lot number: FK5618. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111153 same product and event, different patients;US-PFIZER INC-202200111144 same product and event, different patients;US-PFIZER INC-202200111162 same product and event, different patients.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or concomitant medications was provided. On an unknown dates since 14-SEP-2015, the patients were vaccinated with the doses of (Merck) VARIVAX injection, lot # L011084 with expiration date 01-APR-2017, lot# L019130 with expiration date 27-MAY-2017 and lot# L015047 with expiration date 29-APR-2017 (dose and route of administration were not reported), which had been exposed to temperatures outside of the recommended range. No adverse experiences were reported. Additional information has been requested.
Information has been received from a physician concerning a female who was vaccinated with Varivax (Lot # 654520/1152F) instead of Zostavax. The reporter states that this was a staff error and not product confusion. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint. Additional information has been requested.
continued arm pain after 12 days.  goes from my shoulder down to my forearm.; The is a spontaneous report from contactable consumer.  A consumer (patient) reported for self that the 49-year-old male patient received first dose of bnt162b2 (BNT162B2,  COVID19, Pfizer), via an unspecified route of administration on 24Mar2021 16:00  at single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced "continued arm pain after 12 days.  goes from my shoulder down to my forearm" on 25Mar2021 with outcome of not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Reporter wanted to discuss a possible side effect that he is experiencing after he received the firs dose of the vaccine. He did not elaborate further.  No Follow-up attempts are needed. No further information is expected.
From initial information received on 09/23/03 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that an 18 year old male pt received a dose of Menomune, Lot # UB226AB, administered in the left deltoid on 09/18/03.  On 09/19/03, the pt was achy and developed a sore throat, headache, and an all over rash.  In the ER, the pt was treated with Prednisone and Atarax for rash.  The pt is to come in for a visit on 09/23/03.  The pt's recovery status is unknown.  From additional information received on 10/14/03 from a health care professional, it was reported that the pt described the rash as hives on his arms, which measured the size of a baseball.  The pt's full address, past medical history and concomitant medications were provided.  The pt was seen in an ER room on 09/21/03.  A throat culture was done on 09/25/03, which was negative.  The pt reportedly recovered from these events.  No further information is anticipated, this case is considered closed.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO concomitant medication details were provided. NO treatment medication details were provided.
Head tilt back, eyes roll up with eyelid fluttering, not responsive.  Lasting 3-5 seconds.  Re-occurred 2d later.  Admitted for w/u of seizures.
Extraction of the Moderna vaccine from the vial was not consistent with a Moderna technique (i.e. More than 20 booster doses were drawn up from the 15ml vial).
Guillain-Barre Syndrome, lower extremity weakness. Difficulty walking, difficulty moving from a standing to a seated position, falling. Currently under care at hospital. D/C to another facility on 7/6/11.