chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history and no drug reactions/allergies who on 25-MAR-2009 and 17-JUN-2009 was vaccinated intramuscularly with the first and second dose of GARDASIL (0.5ml, lot #: dose 1 661952/1129X, dose 2 662229/1497X) in her thigh respectively. Concomitant therapy  included ZYRTEC, Omega-3 vitamins (unspecified), echinacea (unspecified), NUVARING and vitamin B (unspecified). About 20 minutes after vaccination both times, the patient experienced a "knot " at the injection  site. There were no lab diagnostics studies performed. 1 or 2 days after vaccination both times, the patient recovered. The patient mentioned that whenever she received vaccines in her arm she developed a knot at the injection site and had difficult moving her extremity in that arm. Names of vaccines involved were unspecified. Follow up information has been received from a medical assistant concerning a 23 year old (reported as 24 year old) female floor nurse who on 25-MAR-2009 and 17-JUN-2009 was vaccinated with the first and second dose of GARDASIL (lot #: dose 1 661952/1129X, dose 2 injection site after each injection. The Area was sore for a day or two then resolved. The patient did not make the reporter aware of this reaction until she came into office for the 3rd injection. The 3rd injection was not given. No further information is available.
Developed hives on Face; swelling of lips; relief with Benadryl po.
This spontaneous report as received from a physician assistant refers to her 1 years old daughter. The patient was vaccinated with VAQTA (0.7 ml, Intramuscular, right leg, lot # was unknown) on 24-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. Physician assistant states she thought the healthcare worker withdrew too much vaccine from the vial, 0.7ml. No adverse effects reported at this time. The outcome of event is unknown. Additional information has been requested.
nonresponder p/2complete series; 1 of the prev 2 series was w/Engerix-B; reporter not certain if the other was Engerix-B; currently completing 3rd series; 3rd series is w/Engerix-B;
16 days after dose 1, I experienced a sudden hyperventilation at 7:00pm on March 15, 2021, which I calmed within moments.  Then at 9:00pm on March 15,2021, a sudden fever of 102.5 occurred, giving a significant feeling of unwellness, but with no cold or flu like symptoms.  I took Tylenol and the 102.5 fever dropped to 100 within hours.   The next morning the fever was gone, but an unwellness feeling remained with no cold or flu like symptoms.  Fever returned later that day but only to 99.2 and then was back normal that day.  The next day a uneasy unwellness feeling with no cold or flu like symptoms occurred, with no fever.   The third day I was recovered.   I had no social interactions between the day I received dose 1 on Feb 27.  Symptoms on Feb. 27th were minor.  No fever.
A few hours after my shot, I became faint, light headed, confused and dizzy.  This went away after an hour.  The next day 12/16/09), I was aware of this tingly sensation in my forearms/hands.  I woke up at 5am on 12/17/09 with extreme nausea and some chills, and I began vomiting a few hours later.  It's now 4:42PM, and I have vomited 3 times since this morning.  I can't keep food or fluids down without instantly vomiting.  I'm also experiencing diarrhea and extreme pain in my back (around kidneys).  I also had a fever of 100.2 degrees at around 2:00pm today.  It's now 4:45pm, and I'm having chills, nausea, back pain and stomach pain.   I'm going to try and see a Doctor tomorrow.
On the 2nd dose of moderna, 2nd day after recieving the dose, patient had extreme vomiting, headaches, and weak legs.
1. Extreme fatigue unable to get off the couch for 2 days 2. severe headache 3. severe nausea 4. overall body muscle aches and joint pains 5. chills 6. felt like I got hit in the face with brass knuckles--severe sinus pain 7. right ear pain 8. severe congestion 9. runny nose 10. dry cough 11. overall severe congestion12. severe bloating  13. severe constipation 14. too weak to walk or drive for over a week
Partial deafness, right ear, noted two days after the vaccine was administered.  A ten-day course of Prednisone begun, and hearing PARTIALLY returned two days later.  Unknown if the inflammatory reaction expected of the Moderna vaccine caused the deafness.  Also unknown if the the dosage of Prednisone reduced the effectiveness of the vaccine.  (My history of Meniere's disease does cloud the issue, but I decided to report the inflammatory response to the vaccine as likely relevant.)
Patient states that approximately 8 days after receiving vaccine (Moderna COVID- 19 Vaccine EUA), she experienced redness and swelling at and around the injection site. States area was 6 cm tall by 10 cm wide. States contacted her private provider who referred her back to the Health Department. States went to Urgent Care where she received steroids and antibiotics. States the area has improved however does remain.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. On 18th October 2018, 3 hrs after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: At 14:00, the patient received SHINGRIX. The patient said that 3 to 4 hours after receiving SHINGRIX, his injection site was a little bit sore. During the conversation the patient said that he had the flu injection recently and experienced event (refer case US2018GSK206938). This case has been linked with US2018190930 (patient's wife) by the same reporter.
Felt sick, within 10minutes of feeling nausea, I passed out while teaching class.  23 hours after injection.
Lethargy, Muscle Aches (Calves, Quadriceps, Hamstrings, Intercostal), Right and Left flank discomfort, Chills, Headache.
Sore arm; Swelling of my lymph nodes by my collarbone/neck on injection site side only; Tired; Weakness; A slight sporadic vibration in my lip on the right side that disappeared afer a week; Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck.; Muscle tightness; Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in Arm Right on 25Mar2021 (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC); fish oil (FISH OIL); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). No allergies reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6203) via an unspecified route of administration at Arm Right on 04Mar2021 11:15 (at the age of 62-year-old) as dose 1, single for covid-19 immunisation and reported sore arm and bruising for about a week. Facility where the most recent COVID-19 vaccine was administered reported as pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 the patient experienced really sore arm and swelling of my lymph nodes by my collarbone/neck on injection site side only. Incredibly tired for two weeks with some weakness. A slight sporadic vibration in my lip on the right side that disappeared after a week. Though today is 2 weeks after 2nd dose and swelling of lymph nodes is still visible/tender & tightness near collarbone. Shoulder area is sore feeling muscle tightness down right upper arm (near injection site) muscle/shoulder blade area & up right side of neck. Reporter assessed case as non-serious. Patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event A slight sporadic vibration in my lip on the right side that disappeared after a week was recovered on 2021 and rest all was not recovered.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021385684 Same patient, same product with different dose, partial same event
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in 2011 with batch number AHAVB472AA).   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 Information: GSK Receipt date: The pharmacist reported that, the patient got first dose of Havrix and hasnt had booster administered. Vaccination date and expiration date were asked but not available. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive booster of Havrix, which led to incomplete course of vaccination.
Fever; elevated heart rate (132); painful body aches; headache; nausea.
Same day extreme lethargy, woke up  with severe muscle and joints pain, specifically my hips, general body  weakness, headache, low grade fever 99.4 and taking Tylenol 01/9  still feel lethargic and 1/10 intermittent cough and heaviness when I breathe
This spontaneous report as received from a medical assistant refers to a 12 years old male patient. The patient was vaccinated intramuscularly into the right arm with first dose of 0.5 ml GARDASIL (lot number not reported) in 2010 and the second dose was administered today on 14-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No concurrent conditions or medical history were provided. On 07-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot # J013345) with expiry date: 11-JAN-2015; strength, dose, route of administration and indication unspecified) in the arm. No concomitant medications were reported. The pharmacist (who also administered the vaccine) reported that the patient experienced swelling from injection site down to their elbow, on 07-OCT-2014, after being administered PNEUMOVAX23. The pharmacist participated in a Flu Clinic. No treatment was given. The outcome of swelling was reported as recovering. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Pt exp a local rxn, consisting of warmth & swelling, @ the inject site p/recvd Typhoid;
Information has been received from a physician referring to a female patient of unknown age. On an unknown date the patient was vaccinated with the first and second dose of M-M-R II (dose, route, lot# were not reported). In April 1995, (unspecified date 20 years ago) the patient experienced severe thrombocytopenia after received the second dose. The patient sought medical attention by office visiting. The outcome of thrombocytopenia was unknown. Additional information has been requested.
Information has been received from medical records concerning a black female who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient was allergic to pneumococcal 23v polysaccharide vaccine.  Patient outcome was not reported.  At the time of this report the patient was 55 years of age.  The patient's experience with rofacexib was repored in WAES 0306USA00923.  No additional information was provided.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 02-OCT-2018, the patient was vaccinated with ROTATEQ, (strength and dose were not reported) (lot # R007150 and expiration date: 15-OCT-2019) orally for prophylaxis which "spent too many days in transit" and which was exposed to unknown temperature conditions during transit. There was no previous temperature excursion. The digital data logger was not involved in recording the temperature excursion. No known adverse effects were reported. There was no product quality complaint (PQC) reported.
One day post vax, pt complained of soreness and swelling below injection site with some numbness of left fingers. At the ER, physician noted some erythema/edema of left deltoid. No loss of motion. Neurovasc exam of injection incurred in military service: local allergic reaction. Also experienced flu-like achiness and sensitive skin. .
Per hospital admission notice - admitted 11/15/07 for seizures. 6/27/08-records received for DOS 11/17-11/25/07-DC DX: Global developmental delay.  Presented with status epilepticus with some desaturation at home, generalized tonic-clonic seizures and decreased responsiveness per parent. Cough and nasal congestion noted. Known seizure disorder.
she hadn't felt good, can't stay awake for a few hours; weakness; nodules (in lung, lymph, thyroid, under arm on left side ); hurt everywhere, so much pain; exhausted; nausea; fever; fatigue, debilitating fatigue, exhausted; enlarged lymph nodes; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain) and FATIGUE (exhausted) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain), FATIGUE (exhausted), NAUSEA (nausea), PYREXIA (fever), FATIGUE (fatigue, debilitating fatigue, exhausted), LYMPHADENOPATHY (enlarged lymph nodes) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she hadn't felt good, can't stay awake for a few hours), ASTHENIA (weakness), NODULE (nodules (in lung, lymph, thyroid, under arm on left side )), PAIN (hurt everywhere, so much pain), FATIGUE (exhausted), NAUSEA (nausea), PYREXIA (fever), FATIGUE (fatigue, debilitating fatigue, exhausted), LYMPHADENOPATHY (enlarged lymph nodes) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided. Treatment medication included antibiotics  for patient's lymph nodes in case of possible infection but nothing changed. Patient's blood drawn for  blood test, Catscan and other test were done. It was reported that patient was actively experiencing symptoms and stated that they were getting worse.   This case was linked to MOD-2021-281144 (Patient Link).
Information has been received from a registered nurse concerning her male nephew who was vaccinated with a dose of varicella virus vaccine live on an unknown date. Subsequently, the patient developed a case of breakthrough chicken pox, Unspecified medical attention was sought. There was no additional information provided at the time of this report. No product quality complaint was involved. Additional information has been requested.
Moderna Arm or covid arm and it is a harmless reaction; rash that comes 10 to 14 days after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Moderna Arm or covid arm and it is a harmless reaction) and RASH (rash that comes 10 to 14 days after vaccination) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Moderna Arm or covid arm and it is a harmless reaction) and RASH (rash that comes 10 to 14 days after vaccination). At the time of the report, VACCINATION SITE REACTION (Moderna Arm or covid arm and it is a harmless reaction) and RASH (rash that comes 10 to 14 days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs and treatment medication information were provided. The reporter had seen pictures and videos of other patients who had the vaccine and had this reaction, but did not know exactly how many patients had it.   This case was linked to US-MODERNATX, INC.-MOD-2021-058178 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received , Containing Non Significant Information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058178:Case for another patient
Redness, warmth, bruising, swelling and chills in the evening. Also limited mobility. As of Tues 10/10/17 decreased 40% in size and range in motion is normal.
SKIN REACTION OR ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced skin reaction or allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin reaction or allergic reaction was not reported. This report was non-serious.
Pain in both arms in area of injection site. Nausea and fatigue. Went to er for extreme pelvic pain and admitted to hospital for appendicitis. On antibiotics now
Patient came in to report adverse event that happened the morning after the shot. The area of the injection was very red, with some swollenness, and was hot to the touch. The area was slightly raised. It was mildly sore, but not extremely so. The borders of the red area spread as the days progressed according to the patient. No other symptoms. The patient was advised to alternate between hot and cold compresses and to use Tylenol or advil (whichever the patient preferred or was able to tolerate) and to monitor the area. If it continued to grow or did not resolve, the patient needed to seek care with a physician.
HCP injected in the top of her shoulder and the second it came down on her arm. It sprayed out a little bit; immediate pain; arm soreness, arm has not being able to be used; shoulder soreness; A spontaneous report was received from a consumer, who is a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the events, some of vaccine came out and dripping down on the arm (sprayed out a little bit), immediate pain(that her arm was unable to be used) and had arm and shoulder soreness.  The patient's medical history was not provided. Concomitant medications were not reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 026L20A), intramuscularly for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 on top of her shoulder and experienced some of vaccine came out and dripping down on the arm (sprayed a little bit), immediate pain (that her arm  was unable to be used) and had arm and shoulder soreness. The reporter stated, if she needed to repeat the first dose or second dose just be fine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The event was some of vaccine came out and dripping down on the arm  considered resolved on 15 Jan 2021. The outcome of the events, immediate pain (that her arm  was unable to be used) and had arm and shoulder soreness, was unknown.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 and concerns a 34 year-old, female patient, who experienced the events of immediate pain(that her arm was unable to be used) and had arm and shoulder soreness. The events occurred the same day after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the event is assessed as possibly related.
Severe left arm pain two days later with pea sized nodule and radiation of the pain down whole arm into her fingers
05/18/2022 I started having chest pains. I went to Employee Health at the hospital I work at. My blood pressure was high, and I told them I had pain level of 9 or 10. I went straight to the Emergency Room. They took my blood pressure. I was given several nitro glycerin tablets. I had a EKG, X Rays, Nuclear Medicine Test, Bloodwork and all showed I had a heart attack.  I stayed in the hospital for a week. I have not recovered, I still have blood pressure issues, but it is better. I have seen my Cardiologist and given medications that have helped.
On 12/01/2022 I started experiencing nasal congestion, weakness, and a piercing headache that lasted about 48 hours. I was also unable to sleep and had loss of appetite for several days. I tested positive on 12/2/2022 and spoke to the NP on 12/2 about my symptoms I was put on a four hour cycle of tylenol and advil, afterwards I felt much better. I was also prescribed a course of Paxlovid which I completed at this time.