chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; welts all over her body; itchy; a sore arm; a strong headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), URTICARIA (welts all over her body), PRURITUS (itchy), PAIN IN EXTREMITY (a sore arm) and HEADACHE (a strong headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 004M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, AMLODIPINE, LISINOPRIL and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-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 PYREXIA (fever), URTICARIA (welts all over her body), PRURITUS (itchy), PAIN IN EXTREMITY (a sore arm) and HEADACHE (a strong headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), URTICARIA (welts all over her body), PRURITUS (itchy), PAIN IN EXTREMITY (a sore arm) and HEADACHE (a strong headache) outcome was unknown. Not Provided          Treatment  information includes IV fluids, Benadryl pill and IV and antibiotics. Steroids (prednisone).  The action taken with the drug was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Non-significant follow document received on 09-JUN-2021 and does not contain any new infomation
This spontaneous report as received from a physician refers to a 9 week old patient. On 04-APR-2014, the patient was vaccinated with first dose of expired ROTATEQ, lot # H013539, expiry date 28-MAR-2014, dose (unknown) and route of administration (unknown). No concomitants were reported. No adverse effect reported. No product quality complaint was involved the outcome of events was unknown. No other information was reported. This report is linked to 1405USA006753 and 1405USA006754 by the same reporter link. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The medical history, concurrent history and concomitant medications were not reported.The drug reactions and allergies were none. On 01-MAR-2016 the patient was vaccinated with ZOSTAVAX lot # L033311, expiry date 01-DEC-2016 subcutaneous. On 02-MAR-2016, the patient developed redness, soreness, and what patient described to pharmacist as a knot at the injection site (which could not be further clarified). Patient then developed warmth at the injection site on 03-MAR-2016. On an unspecified date "over the weekend (05-MAR-2016-06-MAR-2016) she developed a rash all over her face. The rash does not hurt or itch. She also reported that the patient still had a hematoma at the injection site that developed on 03-MAR-2016 that was "the size of a silver dollar. No treatment was given for the events. No lab tests were performed. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Dose administered the 30 day beyond use date 27DEC22; No adverse event; received expired Moderna COVID-19 vaccine on 29DEC2022; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022), PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, 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 29-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022), PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (received expired Moderna COVID-19 vaccine on 29DEC2022) and PRODUCT STORAGE ERROR (Dose administered the 30 day beyond use date 27DEC22).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. The individual vial size was 2.5 ml. Based on 30 day beyond use date was 27DEC22, the vial was thawed on 27NOV2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-695591.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695591:41 year old patient
Dizzy, headache. Left chest pressure. Said she has an appointment with cardiologist this week. She was seen in Emergency room last week with same complaint and was told it was bone or muscle, not heart. All symptoms resolved when she left.
Pt developed nausea vomiting SOB within 24 hours of receiving influenza shot
PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING CLEARANCE FROM HER PCP. DUE TO HISTORY OF ANAPHYLAXIS PATIENT MONITORED BY PROVIDER AFTER ADMINSITRATION OF VACCINE. WITHIN 20-30 MINS OF ADMINISTERING VACCINE PATIENT DEVELOPED COUGH AND COLOR CHANGE IN EXTREMETIES. PATIENT TRANSPORTED DOWN TO ED FOR FURTHER EVALUATION.
November 7th, 2002 patient was given routine 2m vaccines. He was initally noted to have increased irritabilty, but was afebrile. four days later he became lethargic and on the sixth day vomited, and was noted to be floppy. He was taken to the ED and then admmited to the PICU for futher w/u.  Nurse follow up on 06/30/04 states: "ADD: encephalomyelitis, ADD: Floppy."
These symptoms lasted 3-4 days:  Extreme sleepiness; inability to open eyes; tremors; delusions/hallucinations; non-ambulatory; required assistance to sit, in and out of bed, in and out of chair, in and out of bathroom;  tremors; anorexia; difficulty swallowing; slurred/difficult speech; hypotension; aches on right side hip, waist, leg, back;  Required 24-hour supervision/caregiving.  Marked improvement on Day 5; by Day 6, at 80% improvement.  FOR ITEM 20 BELOW, we are indicating "unknown" as the patient is still not 100%.  FOR ITEM 21 BELOW,  we had a conference call with the primary physician, but not an in-person office visit.
Pt cried for 6 hours straight. Had fever this AM of 102.2. Has redness at injection site of left thigh. Pt given Rx of Keflex 250mg/5ml 2 ml PO TID x 7 days.
I didn't feel very good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't feel very good". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Context: The patient stated that she wanted to try to see if she can report what she thought was a side effect from the Pfizer COVID-19 vaccine but she also was wondering if this was something that other people have reported. So she received, she had to get the vaccine for work. The patient's employer required it, so she got 2 doses of the vaccine and then she also required a booster. After the first dose, she did not have any problems, but she did not feel very good which she was informed to be expected.  No follow-up attempts are possible. No further information is expected.
The afternoon of receiving the first Pfizer COVID-19 vaccine, expereinced severe vertigo episode. Disequilibrium persisted resulting in order for an MRI. MRI did not reveal mass effect or acute infarct. Referall to ENT for further investigation pending.   Ongoing disequilibrium from the first event affected requirements of daily living and balance at level that significantly impaired safety and functioning.
Fever 103.2 on 2/6, body numbness on 2/6, vivid dreams - 2/5-2/6, arm feels like needle is still in it - 2/4 - ongoing, headache - 2/5-2/6, sluggish/lethargic - 2/5 - 2/7, difficulty sleeping (wakes often) - 2/5-2/7, loss of appetite - 2/5 - 2/6, twitching - 2/6, increased heart rate (wears a smart watch) - resting 80bpm normal, increased to 105 bpm (2/6). These are the symptoms as of 2/7. Log will be kept to identify any future symptoms that may develop. Dates indicated are all day within range provided.
had covid; had covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) 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 Dec2022, outcome "unknown" and all described as "had covid". clinical course: Medication: Pfizer covid-19 vaccine. Patient states she had covid in dec.  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 available information and temporal association, the causal relationship between the reported events Drug ineffective and COVID-19 cannot be excluded for the suspect product BNT162b2.
The following day after receiving flulaval injection, patient started to get a red welt around the injection site. It was also very warm to touch. Over the next few days, the area of redness spread and then started to turn purple like a bruise. The area, which patient states took up most of her upper arm, was also still very warm to touch. Skin discoloration is fading but you can still see some residual today 3 weeks later.
First I had a fever and flu like symptoms but on top if that I started getting hives on more sensitive areas like behind my knee and the inside of my arms. Then, it started getting worse. The hives started spreading out and getting larger over the week. Then, my throat was feeling like I had a swollen throat. It was hard to swallow a little bit. By the third day, was when that happened so I called my doctor. I had a virtual visit on May 7th. Two days later, I developed Pruritus on lower extremities. On the third day, I developed palpable hives on upper leg. It was hard to sleep because it was extremely itchy over night and I took Benadryl. The hives spread and they were on my face, too. Sensation of tightness in anterior neck. I had a tightness in the back of my head and I felt dizzy. In terms of management, they told me to take Claritin or an antihistamine. All the symptoms lasted for about a week. I took Zyrtec. During that whole week, I had trouble with my equilibrium in a way. I've had a few occasions after than, at least twice a month after that, I've gotten dizzy to the point I couldn't move or get out of bed. That happened for at least 3 or 4 months.
Febrile, with max. temp 102, stiff neck, HA, back pain, joint pain, arm pain.
This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccinated with improperly stored inactivated VAQTA (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. states her arm never hurt, and never itched. She brought in picture on her phone today to be sure that it looked ok today. Saturday, the swelling and rednesss from the picture, went all the way around her arm, and took up the entire upper arm. Today, barely noticeable, but she wanted it documented in her chart as it was pretty significant on the pictures. The redness and swelling was not only where the injection was, but also the other side of the arm.
Patient reported arm was swollen with huge red patch expanding over the injection site.  It was also very itchy.  The patient self treated with Benadryl cream and symptoms resolved after 4-5 days.
After receiving shot #2, the pt developed pain and stiffness of hands and pain to left joint when walking and stiffness to neck after third shot in addition to the above. Started to develop pain in his elbows and lower back, hand joint pain continues to increase with time. He received his first shot on 04/25/1999, his second on 05/24/1999 and his third on 05/25/2000.
Immediately after injection the site was warm and tender to touch; approximately 5 hours later my arm hurt so badly I could barely lift it; I had body aches especially my hips: I had a horrible headache and a fever. My symptoms lasted about 20 hours. Today the only symptom I have is mild tenderness at the injection site. All other symptoms have resolved themselves.
Haven't been feeling great; pain in the eyes; feels kind of dizzy; pain in the joints; Headache; A terrible reaction, pain from the hair of their head to the bottom of their feet; fever 103.2 ºF, fever of 100.2 ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and PYREXIA (fever 103.2 ºF, fever of 100.2 ºF) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet) and PYREXIA (fever 103.2 ºF, fever of 100.2 ºF). On 29-Jan-2021, the patient experienced EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), ARTHRALGIA (pain in the joints) and HEADACHE (Headache). On an unknown date, the patient experienced MALAISE (Haven't been feeling great). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), PYREXIA (fever 103.2 ºF, fever of 100.2 ºF) and ARTHRALGIA (pain in the joints) had resolved and DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and HEADACHE (Headache) had not resolved.
The eye doctor visit on January 10 2022 and diagnosis is allergic conjunctivitis. Could be auto-immune - in some patients it does reoccur as a disorder, per doctor. Resulted in severe eye irritation, swelling, redness, pain  - as if I was looking through a fog. Originally prescribed Bepotastine Besilate 1.5%. Loteprednol Etadonate 0.5%. Antihistamine drops, with a mild steroid drops. Didn't really help so I went back again and she took me off the drops and put me on stronger steroid drop Prednisol Acetate 1% drops. After about 10 days it started to resolve and eventually subsided. Another illness on March 1, 2022 - COVID like symptoms, high fever for 3 days. Negative for COVID via Rapid w/Control test. Resolved, but over the course of the next week or two, I began to notice rash and small hives. Diagnosis  -Guttate Psoriasis - can be auto-immune - indicated sickness from march may have been strep and it moved to my skin. On mild steroid cream and antibiotics twice a day and issue seems to be resolving.
Weak and dizzy; Weak and dizzy; tired; couldn't lift left arm without pain; unsteady on my feet; felt like a hangover; trouble with perception driving home; This is a spontaneous report from a contactable consumer (patient) reported himself that a 76-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: el949), via an unknown route of administration in left arm on 11Feb2021 at 11:00 (at the age of 76-years-old) as dose 1, single for COVID-19 immunisation. Facility type vaccine was other. The patient's medical history included high blood pressure, GERD (Gastrooesophageal reflux disease) and high cholesterol; all were from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included carvedilol (CARVEDILOL), potassium (POTASSIUM), pantoprazole (PANTOPRAZOLE) and acetylsalicylic acid (ASPIRIN 81); all were taken for an unknown indication from an unknown date. No other vaccine in four weeks. On 11Feb2021 at 23:15, the patient experienced weak and dizzy, unsteady on my feet, tired, felt like a hangover, had some trouble with perception driving home. By the evening couldn't lift left arm without pain. These symptoms came in waves all day long. At times had to lie down, and at time felt better, then worse. Today feeling better about 80% ok. Still cannot lift arm but somewhat better. No COVID prior vaccination. No covid tested post vaccination. No treatment received. Still cannot lift arm but somewhat better. Question is should I take the second shot in three weeks considering the side effects. The outcome of the events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Left arm swelled up/raised immediately after giving PREVNAR. The swelling was about 1/2 inch in circumference. No other symptoms. Had patient sit for 15-20 minute. Swelling went down slightly in this time. Still no other symptoms. Advised to patient to take Benadryl if swelling got worse and to contact his doctor or us if it gets worse.
Rash in whole body; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 04Apr2021 at 18:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 09:00, the patient experienced rash on the whole body. Therapeutic measures were taken as a result of rash and included treatment with BRANDIL. The clinical outcome of the event rash on the whole body was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
7 weeks after 2nd vaccine (given 01/16/2021) patient I developed a DVT in LLE.  I have no underlying health conditions, I have no risk factors and am in excellent health.  Described as an "unprovoked DVT."
@ 1230PM pt was noted to be pale w/distressed, almost gasping resp;
Upon returning from break at 11:30am, I went back to the mixing room and grabbed two Pfizer vials that were in a clear bin with no orange UB dot on them. I mixed the vials and drew doses of vaccine in preperation to administer them to TMs coming in for their booster doses of Pfizer vaccine.  At around 1:30pm RN team lead reported to my desk and asked if I knew where the two vials of Pfizer that were in the bin had gone; I acknoledged that I took the vials to dilute them and use them to administer doses to TMs.  He advised me that those doses were empty vials of used vaccine.    I acknowledged the information and let employee know that practice at this vaccination site since opening of the site Feburary 2021 has been to place wasted/empty vials in a clear ziplock bag so they do not get mixed with vials to be used for dilution and to place an orange dot on the pharmacy tag once mixed with the BUB (Best Used By) time; he acknowledged same.  I notified medical director occupationl medical services, and manager occupational medicine, of incident.  All TMs notified of same.
Information has been received from a nurse practitioner concerning an 83 year old female consumer who on 14-FEB-2008 was vaccinated SQ with a 0.65ml of ZOSTAVAX.  Concomitant therapy included acyclovir (ZOVIRAX) and clorazepate dipotassium.  Subsequently, on 20-FEB-2008, the patient developed shingles.  Unspecified medical attention was sought.  It was unspecified if lab studies were performed.  It was reported that the patient was treated for shingles (treatment regimen not reported) and made a full recovery.  It was also reported that the patient went on vacation and when she returned from vacation she developed pneumonia and died on 12-APR-2008.  There was no product quality complaint involved.  The cause of death was pneumonia.  The nurse practitioner considered the event to be disabling.  Additional information has been requested.
Received Flu vaccine on 10/17. Began feeling "funny" neck lymph node  swelling on right side, woke up on 10/19, not feeling well, neck was painful, difficulty breathing, cough, sore throat, progressively worsening thru out the day. Went to ED for evaluation. Patient was seen/treated by Dr.
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L046899, expiration date: 23-FEB-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 2 days. There were no previous temperature excursions reported. Data logger was involved. No adverse reactions were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA009938: US-009507513-1703USA009937.