chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very bad chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 29Jan2021 14:45 at a single dose for COVID-19 immunisation. Medical history included diabetes, cancer and sleep apnea. Concomitant medications were not reported (received within 2 weeks of vaccination). It was reported that 24 hours after getting the shot (30Jan2021 03:00 PM), she had a very bad chills, they lasted at least an hour. 12 hours after that, she got the chills again and 12 hours after that, the same thing. She took acetaminophen (TYLENOL) and that seems to help. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovered on an unspecified date.   Information on the lot/batch number has been requested.
BODY ACHING; COULD NOT MOVE; TROUBLE BREATHING; SWEATING; SLEEPY/SLEEP MOST OF THE DAY AND NIGHT; NO ENERGY; FELT TIRD; HEADACHE IN THE BACK OF HEAD; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included knee replacement, and concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sleepy/sleep most of the day and night. On MAR-2021, the subject experienced no energy. On MAR-2021, the subject experienced felt tird. On MAR-2021, the subject experienced headache in the back of head. On 09-MAR-2021, the subject experienced trouble breathing. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced body aching. On 09-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, body aching, and could not move, had not recovered from trouble breathing, and headache in the back of head, and the outcome of no energy, sleepy/sleep most of the day and night and felt tird was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
fever>101.2 and dry heaving (unable to vomit due to lack of eating)
Extreme joint pain, sore muscles, headache, stomach ache, fever, throat tightness.
I had coughing, fatigue, weakness, a fever, some crackling in my lungs. My husband and I were on vacation, we had packed home COVID-19 test, it came back negative. The next morning, I went to the local emergency room. The did a PCR rapid COVID-19 that came back negative, I had a chest x-ray that showed that I did have fluid in my lungs, I had a nasal swab that came back negative for viral pneumonia. It was determined I had bacterial pneumonia I was given an antibiotic that has helped me to recover. I am still tired but feeling better.
Starting about one day after the injection the site of the injection turned red, warm to touch,  and hard. 5 days post injection the site is still hard and warm to the touch. There are sporadic hives on the same arm as the injection site and some mild itching.
Pfizer-BioNTech COVID-19 Vaccine EUA Chills and fever in the early morning. Started around 3 or 4am the day after my 2nd shot. Head and neck ache, muscle stiffness, fatigue, no appetite, and pain in joints.
Achy and fatigued body. Took 2 alive and was back to normal about 3-4 hours later.
Injection just before noon on Tuesday. Very tired that night after the injection. Starting at 0300 the following morning, had hard shaking chills. Fever got as high as 103.8. Generalized aches, bad headache. Fever finally broke Thursday afternoon.
Patient was in the clinic for a routine physical and Mother requested for patient to start the COVID-19 Pfizer series. A Pfizer 5-11 year old Bivalent dose was given as first dose in error instead of a Monovalent Pfizer primary series dose. Mother was notified and voiced understanding. Mother reports patient is doing well.
Lightheadedness, nausea, headache, chills, sweating, joint and muscle pain
Narrative: COVID infection following COVID vaccine series 03/30, Pfizer, dose #1 04/23, Pfizer, dose #2 08/06 pt cc: headache, loss of taste or smell, fatigue, headache, exposure: unknown 08/09 COVID swab, result: detected
AT THE TIME OF THE INJECTION, ALMOST INSTANTLY TONGUE ENLARGED. TOOK ORAL BENADRYL, AND SAID SYMPTOM WAS SIMILAR TO REACTION HAD BY KIWI. PATIENT CLAIMED THAT MOTHER HAD SAME REACTION WHEN SHE WAS GIVENTHE COVID VACCINE AS WELL.  THE LIQUID BENADRYL SEEMED TO HAVE REDUCE THE SIZE OF THE TONGUE. ALSO, CLAIMED THAT GLANDS WERE SLIGHTLY ENLARGED.
20 minutes after got a rash in the neck, took allegra 180mg, same day 1 hour after same left arm pain, next day shivers,  chills, body aches took Tylenol 1gr every 8 hours
I had my vaccination on 09/25/2022. I had an abnormal EKG 12/22 and my doctor stated I was in atrial fibrillation. The doctor was going to shock my heart back into sinus rhythm but it fixed itself on its own.
prolonged post vax pain, swelling & fever w/nausea; extent of hard swelling, redness & pain extreme for DTP; extensive & prolonged local rxn to same vax in other pts all from same vial;
A few weeks after receiving the first dose of Moderna, I started to experience numbness and tingling in my left hand, in April I started to have constant ringing in my ears, in June I started to have a headache that would not go away, in July I started to get pins and needles feeling in my hands and in my feet, random muscle twitching all over my body, electrical shocks down my face, and tingling in my lips.
High fever beginning 14 hours after vaccine (102), still have fever after 60 hours (down to 100). Entire upper arm around injection site is pink, swollen, painful and hot to touch.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The patient's past medical history included Fatty liver on 05-Jan-2010 and Dyslipidemia. Previously administered products included for Product used for unknown indication: J&J (J&J 1808980; 0.5mL; Intramuscular-Arm.) on 09-Apr-2021. Past adverse reactions to the above products included No adverse reaction with J&J. Concurrent medical conditions included Diabetes since 2010 and Hypertension. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN XR), INSULIN ASPART and INSULIN GLARGINE for Diabetes, ATORVASTATIN for Dyslipidemia, CANDESARTAN for Hypertension. On 24-Jan-2022 at 8:50 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022 at 8:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL). On 24-Jan-2022 at 8:50 AM, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive Type of test - Unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL). Allergic history was reported as none. No treatment information was reported.
Patient received HPV 9 vaccine on 06/08/2015. Patient did not have allergic reaction in the office. Patient left and went to the bus stop and experienced a seizure. Patient had a follow up with neurology. Can not confirm is this was due to the vaccine.
This spontaneous report was received from a consumer, and refers to a male patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced a lot of redness and swelling around the site of administration (left shoulder). He also mentioned that it felt like he was punched in the arm, so there was also pain at the site. At the reporting time, it was unknown if the patient had recovered from the events. Causality assessment between therapy with PNEUMOVAX 23 and the events was not provided.
This spontaneous report as received from a licensed practical nurse refers to a 2 months old female patient. The patient was vaccinated with an expired dose of lot # (669523/1556Z: exp date 12-SEP-2012) ROTATEQ on 18-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-OCT-2012 the patient experienced regurgitated most of the dose during administration. No treatment was given for the event. It was unknown of the patient sought medical attention. The outcome of regurgitated most of the dose during administration was unknown. The relatedness for the reported event was not provided for ROTATEQ. Additional information has been requested.
RT THIGH RED BUMP 2CM X 5CM, INDURATION AREA ABOUT 5CM X 4CM.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 08-JUL-2016 the patient was vaccinated with improperly stored doses of VAQTA lot # M011116 expiration date 17-JUN-2017. Dose, route and anatomical location were not provided. No other suspect or concomitant medications were reported. Excursion details: cumulative time frame for two excursion between 07-JUL-2016 and 08-JUL-2016, 30.3 Fahrenheit degrees for 7 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. (1607USA009450) Additional information has been requested.
This spontaneous report was received from a pharmacist regarding an adult patient of unknown demographics. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date in 2015, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB (dosing details and lot # were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse events were not reported. No product quality complaint.
Pt recvd series of 3 Engerix-B 31JUL90, 12SEP90, 25JAN91 for Hep B vax & was a poss non-responder;
hospitalized for covid 19 pna.  - She feels terrible.  She is complaining of shortness of the breath and muscle pains and aches.  Her oxygen saturation is low and now she is requiring oxygen supplementation.  Needing 4L of O2. smoker.
Shoulder pain and ROM loss on L shoulder within days after vaccination - resulting in md visit and subsequent referral to surgeon/MRI in September of 2020. Pt still complains of pain in shoulder and range of motion limitations today.
Rash started on neck, spread to chest & face.  Small red bumps, itching.
Received flu shot in left deltoid. Developed itchiness, rashy skin around injection site. Itchiness traveled up into neck and upper back. No local rash seen by this RN.
Initial report was received from a health care professional on 29 2011 who is also the patient. A 51 year-old female patient with allergies to DEMEROL and horse serum had received a left arm injection of ADACEL, lot number C3921AA (route of administration not reported) on 24 June 2011 and by the evening of vaccination began to have soreness at the injection site. The next morning the patient experienced an itchy, swollen, red, hot to touch upper arm with hard spot the "size of palm" at the injection site and a sore arm. The patient reported that the arm soreness had been severe enough that she had been unable to sleep on her side. Concomitant medication included aspirin. Treatments were not reported. Illness at the time of vaccination and other vaccines with in four weeks of suspect were reported as none. The patient had no history of any medical conditions. No further information was provided at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Chills, started at 9:00pm, still sick all next day Fever Headache Cough  Runny nose Nausea Lack of appetite  Fatigue
Atrial fibrillation  15 hours after administration.  emergency room administered saline, diltiazem and apixaban.  By 10:00 A. M. Friday (26 November 2021) my heart was maintaining normal sinus.
Patient presented with chronic onset chest pain, worsened by breathing and coughing, gave Lipitor, Famocidine, Aspirin, Tylenol, and Discharged.
Chills; Fever; Feeling bad; Very tired; Patient was feeling very very weak/ had no strength to do anything; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Patient was feeling very very weak/ had no strength to do anything), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 30-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Apr-2023, the patient experienced ASTHENIA (Patient was feeling very very weak/ had no strength to do anything), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired). On 01-May-2023, the patient experienced CHILLS (Chills). At the time of the report, ASTHENIA (Patient was feeling very very weak/ had no strength to do anything), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient started feeling bad since 30-APR-2023 during the night and arrived home to sleep because she was very tired, and next day patient felt really bad, with chills, very tired, Patient did not have strength enough to do anything, this was still ongoing but improving.  No treatment information was provided.   This case was linked to MOD-2023-723032 (Patient Link).
On April 3rd I had heart palpitations, and my heart started beating rapidly. It was hard to breath. I felt flushed and lightheaded. I had tingling in arm and hands. I believe I had a panic attack and anxiety that I have never had previously in the past. It happened periodically over the next couple months. It ceased for a couple of months and then came back in August 2021 around the time I got COVID-19. I had caught COVID-19 about 5 months later after getting the second vaccine. On September 11th is when I tested positive for COVID-19. I have had moderate anxiety and depression with stomach issues. I am currently in the process of trying to get approved for FMLA. I haven't been able to work. I may have to take a leave of absence from work. On September 13th I received the monoclonal antibodies. I've been to the ER 4 times since April 2021. I have been diagnosed with Gerd. The doctor prescribed me Zofran and famotidine due to the nausea and acid reflux. I was also prescribed Prozac, but it made things worse so now I am prescribed hydroxyzine. I started seeing a therapist as well for the generalized anxiety disorder that I was also diagnosed with. I got a series of appointments coming up since getting COVID-19. I'm going to see many different specialists to check up on me.
Pt received 3rd dose of Engerix-B and experienced migraine headache.
Received Shingles vaccine had twice shingles year apart/ suspected vaccination failure; Shingles (2nd time); Shingles (1st time); Debilitating; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had when he or she was young).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received Shingles vaccine had twice shingles year apart/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles (2nd time)), shingles (Verbatim: Shingles (1st time)), weakness (Verbatim: Debilitating) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles, shingles, weakness and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, shingles, weakness and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, shingles, weakness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported he or she was recommended to receive the shingles vaccine. The patient stated he or she received original version of Shingles vaccine and within two weeks of receiving Shingles vaccine he or she experienced shingles.. The patient stated that if you have the chance to receive shingles vaccine get it. The shingles are very debilitating and painful. The patient reported that he or she experienced Shingles two times a year apart. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR049492:Same reporter
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medication was provided
I began with lightheadedness and then I had nausea. I never did throw up. I had a faint feeling. I had aches and pains and low-grade temperature. I also had a headache and earache. I also had a loss of appetite. I was really sick for 24 hours. I did take ibuprofen. After a few days I was back to normal.
I fainted twice the following day after my vaccine shot and hit my head against the hardwood floor. I first fainted at around 4:00 AM on March 24, 2021 after waking up. My parents carried me down the stairs and I fainted again after that. I didn't receive any treatment afterwards. I had a fever for the entire day and was feeling dizzy and nauseous for most of that day. I haven't fainted since then but still feel a little bit dizzy every once in a while.
patient felt dizziness and faint after receiving the shot . She laid down to due to feeling like she would pass out.
Patient states that after receiving the 1st dose of Pfizer 03/10/2021, started experiencing symptoms that evening of fever (102.0), fatigue, muscle aches, joint pain, and dizziness. Lasting 7 days and self-treating with Over-the-Counter Tylenol.
Leg swollen, warm to touch, bruised. Hands and feet swollen with welts on day 3.
for first week and a half a large red burning circle (like a sunburn) apron 2" x 2" painful for about 20 minutes if rubbed. It is 2 weeks later and it is now a large bruise (appears to be a bruise) still painful when touched. Numerous headaches since injection, but I think those finally slowed after two weeks. Have some joint pain all over.  This is after the first shot
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-FEB-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
10 days after the shot and I still have a large knot in my arm where they gave me the shot.  It's still swollen and it itches.  The day after the shot my back started to ache.  2 days later I had so much pain in my back I could hardly move.  It's taken over a week for the pain in my back to subside but it's still there.
numbness, difficulty breathing, physical shaking, disassociation w/reality, dizzy, nauseated, diarrhea, vomiting, h/a, adrenalin surges, body aches, lightheaded, rash, flashes, dec appetite, hostile, paranoid, hot/cold, irritated;