chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022). No concomitant product use was reported. Reportedly, Patient received half dose. Vial did not undergo any temperature excursions. No treatment information was provided.
my back starts hurting really bad; legs all the down from knees to end of my toes are just numb; start trembling as soon as I start walking; no balance; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (no balance), BACK PAIN (my back starts hurting really bad), HYPOAESTHESIA (legs all the down from knees to end of my toes are just numb) and TREMOR (start trembling as soon as I start walking) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029C20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), SIMVASTATIN, L-THYROXINE [LEVOTHYROXINE] and OXYCODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced BALANCE DISORDER (no balance) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced BACK PAIN (my back starts hurting really bad) (seriousness criteria disability and medically significant), HYPOAESTHESIA (legs all the down from knees to end of my toes are just numb) (seriousness criteria disability and medically significant) and TREMOR (start trembling as soon as I start walking) (seriousness criteria disability and medically significant). At the time of the report, BALANCE DISORDER (no balance), BACK PAIN (my back starts hurting really bad), HYPOAESTHESIA (legs all the down from knees to end of my toes are just numb) and TREMOR (start trembling as soon as I start walking) outcome was unknown.            Treatment of these events were not reported. Action taken with mRNA-1273 in response to the events was not Applicable  Company comment:This case concerns a 62-year-old female with serious unexpected events of balance disorder, and nonserious unexpected back pain, hypoesthesia, and tremor. Event onset 4 days after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 62-year-old female with serious unexpected events of balance disorder, and nonserious unexpected back pain, hypoesthesia, and tremor. Event onset 4 days after second dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
My elbows started itching then hives covered my body very quickly.  Swollen red hives all over.
she only had a sore arm after the first three doses; she only had a sore arm after the first three doses; Sore arm; This is a spontaneous report from a contactable consumer (Patient's husband) reported for 66-year-old female patient (reporter's wife) via Medical Information Team. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), dose 3 via an unspecified route of administration on 24Aug2021 (at the age of 66 years old) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medication included hydrocortisone (HUMERA) for rheumatoid arthritis from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) on 04Feb2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) on 26Feb2021 for covid-19 immunisation and patient experienced she only had a sore arm after the first three doses. Reporter was on behalf of his wife who has received four total Pfizer BioNtech covid 19 vaccines. They were on 04Feb2021, 26Feb2021, 24Aug2021 and today respectively. Today she was supposed to get a flu shot and was accidentally given a fourth dose of the Pfzer BioNtech covid 19 vaccine. She has not had any side effects so far. Reporter reports that she only had a sore arm after the first three doses on an unspecified date in Aug2021. Reporter also reports that she has RA and has been on Humera for the past 15 years. Seeking information on safety after this error of the 4th dose. Reporter considered events as non-serious. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
THE PATIENT WAS SUPOSED TO RECEIVE PFIZER BIVALENT. HE WAS GIVEN PFIZER BOOSTER INSTEAD.
FAINTING; This spontaneous report received from a consumer via a company representative concerned multiple patients.  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 administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The consumer reported about the article which said that multiple people on 07-APR-2021 experienced fainting after receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting on unspecified date in APR-2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210420898.; Sender's Comments: V0: 20210421103-covid-19 vaccine ad26.cov2.s-fainting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
-Fever of 103°F 18 hours after vaccination -Difficulty breathing 0.5 hours after vaccination and continuing for the next 48 hours -Rapid heart rate 4 hours after vaccination and continuing for several hours -Extreme fatigue 12 hours after vaccination and continuing for 24 hours
I was taking VIVOTIF for about a week and had carried on as one would normally. However, by Friday, I was having bouts of diarrhea, sometimes with streaks of blood. On Friday and Saturday evenings, I felt generally unwell, feverish, and fatigued. On Saturday evening specifically, my stomach was in pain, as if I had very bad heartburn. Since finishing the vaccine, the diarrhea and worse side effects have subsided but still persist to some degree: being overly tired by the afternoon and loose stools.
Pt presented to office on 06/06/02. Mother reported onset of rash 06/05/02 per doctor rash consistent in appearance/presentation with chicken pox. Child received varicella vaccine on 05/28/02.
Information has been received from Merck Pregnancy Registry for GARDASIL from a Nurse practitioner concerning an 18 year old female with AUGMENTIN allergy and no pertinent medical history who on 06-OCT-2008 was vaccinated with first dose of GARDASIL (Lot # not reported). Concomitant therapy included ZOFRAN. On 08-DEC-2008 she received second dose of GARDASIL (Lot # not reported). When she received second dose of vaccine she was pregnant. Patient had last menstrual period on 13-NOV-2008. Estimated date of delivery was 29-AUG-2009. The nurse practitioner reported that the mother delivered a female that has been diagnosed with Laryngomalacia. According to the nurse practitioner, a few days after the birth, the mother brought the baby into the Emergency Room at their hospital with stridor and the baby was transported to a Department of Otolaryngology in a university for care. She said she was told "the baby has extra tissue in the throat", and "along with the stridor which was related to the laryngomalacia, the baby has had reflux and pneumonia at some point too." The nurse practitioner added that it was congenital, but did not state who provided that information. The nurse practitioner added that the baby was gaining weight appropriately. At the time of the report the baby's status was unknown. The infant's laryngomalacia was considered a congenital anomaly. The mother's experience is reported is WAES 0901USA03985. Additional information has been requested.
The day after vaccine was given, the pt had a fever, weakness, joint aches (states she could barely move) and "felt funny". She did miss 2 1/2 days from work but did not see a doctor and did not call a doctor's office. A follow up report received 11/1/2001 adds: Reporter states that pt did have labs drawn but didn't see her physician. She has subsequently recovered. She had no other vaccine at this visit and no other in the previous 4 weeks. She did report "achy" 2 years ago with flu shot then but no severe effects.
Fever 101.7 Extreme fatigue  Nausea  Headache  Flu-like symptoms    Injection at 5:10pm, symptoms were in full effect about 12-14 hours later.
Received second shines shot on Friday, September 28th around noon. Woke up after midnight that night with a severe headache and chills. Did not have this reaction with the first shot in the series, only a very sore arm. Arm was not as sore with the second shot. I did receive the shots at two different pharmacy locations.
Leg cramp on 02/14/2012 at 7:00 PM. At 11:00 PM client woke up with chills and had no temp. 02/15/2012 client had a fever of 100.6 at 5:00 AM. Advil and currently complains of headache and nausea.  Advised to call MD.
(R) facial swelling & redness developed at daycare on 6/9/11 with fever 102 overnight. No other symptoms. No runny nose. No cough, acting fine on exam on 6/10/11 at 4pm noted (R) lower cheek/jaw parotid gland firm, edema, mild redness nontender to gentle palpitation. Jaw has full ROM. Exam negative otherwise/impression Parotiditis secondary to MMR vaccine with fever.
3/29/11 complained that he felt like "he was burning up". Extreme shoulder pain. 3/30/11 stomach upset, chills & extreme shoulder pain. Dr. recommended Ibuprofen.
20 minutes after the shot, I developed chills. I took Tylenol and drove home. I went on to develop myalgias, and severe fatigue. The next day, my left arm hurt and I developed a red patch around where I received the shot. The important thing was that the red area spread all over my upper arm and became hard, indurated, mildly swollen and very itchy and didn?t resolve for at least 2 weeks. It?s 3 weeks out and the area is still mildly discoloured, (red), though I have no pain, hardness or swelling. I think antihistamines helped.
pt recv vax & 2 days later pt devel a rash on forearm, which was distal to inj site;MD suspected poss hypersensitivity & recommended no further vax
Is it normal for my blood pressure to be elevated the day after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Is it normal for my blood pressure to be elevated the day after the vaccine) 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 BLOOD PRESSURE INCREASED (Is it normal for my blood pressure to be elevated the day after the vaccine). At the time of the report, BLOOD PRESSURE INCREASED (Is it normal for my blood pressure to be elevated the day after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
I received the Covid-19 vaccine on 10/06/2022. On the morning of 12/20/2022 my chest was tight, headache and sore throat. By the 23 I went to urgent care and was testing positive for Covid-19. I was prescribed PAXLOVID. I started feeling fine quickly however I got re-infected with Covid 19 again on 01/03/2023. Symptoms came back.
No signs or symptoms reported. No other AE or PQC reported; Pharmacist called to report a temperature excursion / M-M-R-II was given on 18/AUG/2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy, and concomitant medication was not provided.  On 18-AUG-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella virus vaccine, live (rHA) (M-M-R II) 1 time dose (lot #T012806 was confirmed to be valid, expiration date 14-APR-2022; route of administration and anatomical location were not reported) for prophylaxis. The storage temperature was 10, 9.4, and 9.5 (on 13-AUG-2021, 14-AUG-2021, and 15-AUG-2021) Celsius degrees for 1 hour and 27 minutes. There was no previous temperature excursion. No additional adverse event details provided (no adverse event).
Chest pain, chest tightness, and heart palpitations that began about a week after vaccine and have persisted ever since.
discogenic marrow changes; degenerative disc disease; osteoarthritis; chills; low grade fever; Severe backache/Severe low back pain that radiated to right hip; A spontaneous report was received from a consumer concerning a 80 year old, female patient who developed Severe backache/Severe low back pain that radiated to right hip, discogenic marrow changes, degenerative disc disease, osteoarthritis, fever, and chills.     The patient's medical history included blood clots, hypertension and anxiety.  Products known to have been used by the patient, within two weeks prior to the event, included clonazepam, apixaban, lisinopril, and oxycodone hydrochloride/oxycodone terephthalate.     On 28-JAN-2021, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. It was planned for patient to receive their second dose on 03 Mar 2021.   On an unspecified date post vaccination, patient developed low grade fever and chills. On 01 Feb 2021, four days post vaccination, the patient developed severe backache described as severe low back pain that radiated to right hip. An ambulance was called and patient was transported to an emergency room (ER) where an X-ray was done. Patient was then sent home and told to follow-up with her primary care physician (PCP) who referred to a pain clinic. A magnetic resonance imaging (MRI) revealed osteoarthritis, degenerative disc disease and discogenic marrow changes. The patient is unable to have steroid injections because of her use of an anticoagulant.  Treatment information was unknown.    There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s).  The events Severe backache/Severe low back pain that radiated to right hip, discogenic marrow changes, degenerative disc disease, and osteoarthritis were considered not recovered/not resolved.   The outcome of events fever and chills, was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
no adverse event; office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (office discovered that vaccines in inventory were used past there expiration date/vaccines were administered July 13-21 of 2022/vaccines used by date was July 14 2022).    No concomitant medications were provided. No treatment medications were provided. It was reported that the office was aware of 3 patients that had received mention vaccine vials.   This case was linked to US-MODERNATX, INC.-MOD-2023-705204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705204:Master case
This case was reported by a nurse via call center representative and described the occurrence of injection site nodule in a 37-year-old female patient who received FLULAVAL quadrivalent (batch number 93T79, expiry date 30th June 2016). On 23rd September 2015, the patient received FLULAVAL quadrivalent .5 ml. On 23rd September 2015, 3 hrs 30 min after receiving FLULAVAL quadrivalent, the patient experienced injection site nodule. On an unknown date, the outcome of the injection site nodule was recovered/resolved. It was unknown if the reporter considered the injection site nodule to be related to FLULAVAL quadrivalent. Additional detail were provided as follows: On 23rd September 2015, at 11.30, the patient received FLULAVAL QIV vaccine. On the same day, at 3.00, 3 hours and 30 minutes after receiving the vaccine, the patient experienced knot at the injection site (right deltoid). The patient came back to clinic at 3.30 to complain of a knot at the injection site (injection site nodule).
hives; very itchy; very very tired, could not get out of bed; body was aching so badly; had temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (body was aching so badly), BODY TEMPERATURE INCREASED (had temperature), URTICARIA (hives), PRURITUS (very itchy) and FATIGUE (very very tired, could not get out of bed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024MZOA and 011JZOA) for COVID-19 vaccination.     No medical history was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (body was aching so badly), BODY TEMPERATURE INCREASED (had temperature) and FATIGUE (very very tired, could not get out of bed). On 07-Mar-2021, the patient experienced URTICARIA (hives) and PRURITUS (very itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PAIN (body was aching so badly), BODY TEMPERATURE INCREASED (had temperature) and FATIGUE (very very tired, could not get out of bed) had resolved. On 15-Mar-2021, URTICARIA (hives) and PRURITUS (very itchy) had resolved.            Concomitant medications were not provided.  Treatment medications also included:allergic pills, antibodies, and prednisone.   This case was linked to MOD-2021-034649 (Patient Link).
Vasovagal response - patient passed out - began to flail - rigid body - bit lip - pale - weak - monitored patient until escorted to spouse's vehicle at 1420.
For about 4 days after the second shot my eyes felt swollen. I think it was the muscles around the eyes that were swollen as I also had a severe! headache for 2 days that I could feel behind my eyes (and in other areas of my head). It felt like my eye lids were swollen and around my eyes were swollen. I had trouble focusing my eyes for about 3 days; the 4th day my eyes felt very irritated as if I had been crying or had a fever (but my temperature was normal) By day 5 after the shot my eyes felt normal again and I could focus normally.
body aches; Achy sickly feeling; light sensitive behind the eyes; headache; This is a spontaneous report from a contactable consumer (patient). A 63 years old male patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated he took the Pfizer covid vaccine a week ago (on an unspecified date in 2021) and experienced headache and body aches, they went away but he still had light sensitive behind the eyes, achy sickly feeling. Caller wanted to know was that normal, how long they last. The outcome of the events headache and body aches were recovered on an unspecified date in 2021. The outcome of the events achy sickly feeling and light sensitive behind the eyes were not recovered.  Follow-up attempts are completed. No further information was expected.