chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A couple days after the first vaccine injection and persisting until about three weeks after the second injection, I started getting strange spasms that did not involve the entire muscle groups.  It was as if a strand of the muscle was spasming and this was odd because I usually only ever get muscle spasms in my legs after a hard workout.  The spasms started in my left pectoral muscle adjacent to the vaccine injection site in my shoulder.  Later they started in my left thigh, then my right thigh followed by my right pectoral muscle and finally in the muscles over my left and right should blades.  The spasms would persists for about 30 to 45 minutes then disappear several times a day and never in unison.  I did not seek medical advice because other than keeping me awake at night, the spasms did not bother me too much and I wanted to give them time to resolve and they did.  During this time I experienced trouble falling asleep and this persists mildly to this day but maybe once every couple weeks.  In the time when my muscles would spasm the symptom I'm about to describe was happening nightly and when I tried to take naps.  As I was falling off to sleep I start getting points of itching here and there on my body.  Maybe three to six places.  I scratch then continue to drift off until I'm jolted awake.  Its not too severe, my mind becomes more alert I relax again and drift off to sleep.  Again, this has mostly resolved but happens about once every couple of weeks still and sometimes I just get the itching without jolting awake.
Case number PHHY2011US41580 is an initial spontaneous report received from a health care professional on 02 May 2011. This report refers to an adult male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number 090901, expiry date: Aug 2011) on an unspecified date. No other adverse reaction was reported.
Hypertonic, hyporesponsive episode occurring 2 hours after vaccine lasted 30 minutes.
That evening after vaccine given started developing rash on extremities with itching, rash became worse over next several days. Saw PCP on 10/24/2005.
Temp 101.3. Chills,sweating,  headache, neck pain, muscle pain, joint pain, nausea  20 hours after injection.  I had to call in sick to work Moderna COVID-19 vaccine EUA
Fever 105 for 1 1/2 days, eyes glazed over, slow response to verbal stimuli, limp and a rash.
Pt accidentally given 2nd dose of Tdap and Menactra. Prev Vacc of Tdap and Menactra 2/2/06.
Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm; all pain triggers were ramped up, all pain flared up/sore; unable to do anything, take care of myself; thigh hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm), PAIN (all pain triggers were ramped up, all pain flared up/sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything, take care of myself) and PAIN IN EXTREMITY (thigh hurt) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 026B21A) for COVID-19 vaccination.     Concomitant products included BUPRENORPHINE (BUTRANS), MORPHINE, IBUPROFEN (MOTRIN [IBUPROFEN]) and MENTHOL (BIOFREEZE [MENTHOL]) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm), PAIN (all pain triggers were ramped up, all pain flared up/sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything, take care of myself) and PAIN IN EXTREMITY (thigh hurt). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm), PAIN (all pain triggers were ramped up, all pain flared up/sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything, take care of myself) and PAIN IN EXTREMITY (thigh hurt) outcome was unknown.            Concomitant medications include over the counter topical pain medications.   Treatment medications include Prescription Pain Medications, Pain Patches and Topical pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non Significant Followup contains NNI
Initial pharmacist report received on 20 Aug 2010: This patient received Novartis H1N1 vaccine (batch number 102149P1, expiration date 30 Apr 2010) 0.5 ml dose intramuscularly on an unknown date. The suspect product was taken as S-OIV FLUVIRIN conservatively. It was reported that the vaccine (Novartis H1N1) was expired when it was given to the patient. No other information was reported. Follow up report received from the health care professional on 14 Sep 2010: The patient was vaccinated with S-OIV FLUVIRIN, 0.5 ml intramuscularly in the left deltoid on 16 Aug 2010.
pt c/o 3 big raised wheals (rt arm) very painful w/o touching, unable to move arm since 6PM 8OCT98;c/o achiness & fever;pt told to go to ER if persist;pt went to ER & was given decadron & was sent home & was better a few days later;
Red, papular rash on face- 3 lesions, 8 papules on chest, 13 lesion on abdomen- mostly crusted. Began 05/08/2003. Afebrile
Headache; body aches; chills; sweating; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6742) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00); PAIN (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "body aches"; CHILLS (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00); FATIGUE (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "extreme fatigue"; HYPERHIDROSIS (non-serious) with onset 16Dec2022, outcome "recovered" (16Dec2022 at 12:00), described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain, chills, hyperhidrosis, fatigue.  Additional information: Patient experienced headache, body aches, chills, sweating, extreme fatigue, felt very similar to having COVID infection. Adverse reaction started about 10 hours post vax and lasted for about 12 hours . As a treatment medication, patient took a bunch of ibuprofen.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202201384552 Same reporter and patient, different product;
After receiving 1st dose, she felt weak; She had flu like symptoms; She was out of breath; She couldn't walk upstairs; She couldn't eat much; She felt even more fatigued after receiving 2nd dose, She felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (After receiving 1st dose, she felt weak), INFLUENZA LIKE ILLNESS (She had flu like symptoms), DYSPNOEA (She was out of breath), GAIT DISTURBANCE (She couldn't walk upstairs) and FEEDING DISORDER (She couldn't eat much) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 01L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN for Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-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 ASTHENIA (After receiving 1st dose, she felt weak), INFLUENZA LIKE ILLNESS (She had flu like symptoms), DYSPNOEA (She was out of breath), GAIT DISTURBANCE (She couldn't walk upstairs), FEEDING DISORDER (She couldn't eat much) and FATIGUE (She felt even more fatigued after receiving 2nd dose, She felt fatigued). The patient was treated with DOXYCYCLINE for Bacterial infection, at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, ASTHENIA (After receiving 1st dose, she felt weak), INFLUENZA LIKE ILLNESS (She had flu like symptoms), DYSPNOEA (She was out of breath), GAIT DISTURBANCE (She couldn't walk upstairs), FEEDING DISORDER (She couldn't eat much) and FATIGUE (She felt even more fatigued after receiving 2nd dose, She felt fatigued) outcome was unknown.            Patient took Cholesterol Medicine as concomitant (Did not provided the name of the medicine).   This case was linked to MOD-2021-291661 (Patient Link).
The pt received the vaccine on 4/4/01 to the right thigh. the pt experienced a warm, red raised area that was 9 x 7 cm on 4/10/01. No pain, was seen in the office on 4/10/01.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypertension-Medium, Additional Details: Patient reported waves of feeling like her heart was racing shortly after receiving covid vaccine.  BP 143/96, HR 72.   Patient refused to lay down.  Patient then said history of tachycardia, possibly occuring because dinner time and hungry.  I gave her a chocolate chip granola bar and water.  About 30 minutes post vaccination, patient reported chest pain.  I then called 911 and EMS came to assess her.  She opted not to be transported and went home.  She will f/u with her cardiologist.
Initial unsolicited report received from a pharmacist on 20 Oct 2017. This case involves a 72-year-old female patient who was vaccinated with one dose of FLUZONE HD (Batch number, expiry date, dose and dose in series were not reported) intramuscularly in left arm on 10-Oct-2017. Patient medical history was not reported. Concomitant medications were not reported. (It was reported as the patient was not taking any other vaccines). On 10-Oct-2017, immediately after the vaccination, the patient experienced severe muscle pain and cannot able to lift the arm or move it. On an unknown date, the patient was seen by a physician as her conditions was not improved and was prescribed with ALEVE PRN. It was reported as the patient was previously vaccinated with FLUZONE HD (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date in the past without any issues. Relevant lab tests were not reported. Other corrective treatment was not reported. The outcome of the events were reported as unknown List of documents held by sender: none.
No adverse effects reported; the patient was "inadvertently administered an expired dose of ROTATEQ"; This spontaneous report has been received from a medical assistant concerning to a 9-week-old patient of unknown gender.  The patient's concurrent condition, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 26-AUG-2019, the patient was inadvertently administered an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose not reported) (lot#: N022015, expiration date: 10-MAR-2019) administered orally for prophylaxis (Expired product administered). No adverse effects were reported.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR123595   Additional Information: GSK receipt date: 22-AUG-2022 Reporter's comments: This case was reported by the patient via interactive digital media. Patient had 2 shingles vaccines and second made patient sicker than all. Patient said that it was better than 2 months of shingles pain though. Additional Supportive Information: It was reported that "Patient had 2 shingles vaccines and second made patient sicker than all" from this line it was not clear if patient was comparing sickness happened after 2nd dose with 1st shingles dose or any other vaccine hence conservatively sickness was captured as event for 1st dose. Also, it was reported that "this sickness was better than 2 months of shingles pain" from this it was not clear if patient had experienced shingles pain or was only using it as a general statement for comparison hence shingles pain was not captured.; Sender's Comments:  US-GSK-US2022AMR123595:Same reporter
Patient received janssen booster vaccine at around 1:40pm on 12/29/2021. Shortly after at around 1:50 pm patient was observed having his head tilted back and shaking repeatedly. At that moment patient was not alert and oriented, was not responsive to verbal commands. VS signs taken promptly BP: 156/128 , HR 131, RR: 24, T:97.9, oxygen level 96%. 911 called immediately.  While waiting for EMS patient had the same cycle of being in and out and not responding to verbal commands. EMS arrived shortly and took patient to  nearest hospital.
Subsequent to receiving two doses of varicella virus vaccine live the pt did not seroconvert.
my elbow got warm after shot, then day and a half later was the size of a golf ball, was also greenish.  still swollen but trying to nurse it back to normal. also my hands and toes are swollen.
A heart murmur was discovered for the first time about 2 months after the final dose of the vaccine.  I had never been diagnosed with a murmur until I went for a check up in May of 2021.
Fever, delirium, redness, pain and swelling at site of vaccine.  Received antibiotics.  4/1/08 Reviewed hospital medical records for 11/13/2006.   FINAL DX: left shoulder cellulitis s/p vaccination; pathologic lesion right proximal femur; right femur intermedullary nailing.
Vaccine administered 9am 3/22/11. Approx 11:45am pt called PHN with slurring of speech, vertigo, nausea, weakness, tingling in legs and headache. Instructed pt to be seen in urgent care.
pt recv vax & exp a site rxn consisting of redness, swelling & hardness;
no adverse event; HCP called in to report a temperature excursion on VARIVAX and PROQUAD. HCP reports that 9 patients were administered VARIVAX. HCP reports that the VARIVAX administrations occurred on 6/21/22, 6/23/22, 6/27/22, and 6/28/22. The patients involved in t; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in June 2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U024765, expiration date: 10-AUG-2023, for prophylaxis (dose, strength, route of administration and anatomical location were not provided). The vaccine was administered after the temperature excursion (product storage error). No additional adverse event reported.  This is one of the 14 reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008492:
This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced shoulder pain, joint range of motion decreased and joint clicking. On an unknown date, the outcome of the shoulder pain and joint range of motion decreased were recovering/resolving and the outcome of the joint clicking was unknown. It was unknown if the reporter considered the shoulder pain, joint range of motion decreased and joint clicking to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient had severe pain that progressed in intensity starting on day 4 then over a 5 week period in the shoulder the injection was given. This pain was severe and limited movement. The patient continued the water aerobics that had been doing for years. The pain remained constant from about week 6 through week 13 where it slowly started to subside. The pain was minimal at the time of reporting, however there was a lot of popping and grinding noise and some limited movement from the affected joint area. The patient stated that, she needed the 2nd dose and asked if it would be possible to get the vaccine in the buttocks, hip or thigh area.
Wearing off effect; Hives; DOUBLE EAR INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (DOUBLE EAR INFECTION), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and URTICARIA (Hives) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Plaque psoriasis.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. In 2021, the patient experienced EAR INFECTION (DOUBLE EAR INFECTION) and URTICARIA (Hives). On an unknown date, the patient experienced THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). In 2021, EAR INFECTION (DOUBLE EAR INFECTION) and URTICARIA (Hives) had resolved. At the time of the report, THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  On an unknown date, the patient experienced an outbreak about two weeks before. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624906 (Patient Link).
2PM started crying unconsolably, t103; crying & temp cont x 2 days w/hardly any rest; seen by MD;
feel very bad; terrible reaction; chills; vomiting; body aches; headaches; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting) and MYALGIA (body aches) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048cz1, 036421a and 00013m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third 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 (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired). At the time of the report, FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included hbp medicine. No treatment medication was reported. No lab data was provided.
Atrial fibrillation worse; Painful to breathe in; Thirsty; Feeling unwell/ feeling sick; Chills; Fever; Headache; This is a spontaneous case, initially received from other non-health professional via agency (reference number: SEQ19-03323) on 26-Sep-2019, concerning a 67-year-old, female patient.   The patient's current conditions included atrial fibrillation and epilepsy. The patient's concomitant medications included unspecified epilepsy medicine.  On 22-Sep-2019, the patient was administered Fluad vaccine [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number: 260380 and expiration date: Apr-2020] for influenza prophylaxis.   On 24-Sep-2019, two days after vaccination, the patient started feeling unwell, been feeling sick with chills and thirsty, experienced fever, headache and painful breathing. The patient also experienced worsening of atrial fibrillation. In addition, the patient had to take more of epilepsy medicine, but details were not specified.  At the time of initial reporting, the outcome for all events was not reported.  The case was assessed as serious and the reporter did not provide causality assessment.  Company Comment: The patient experienced atrial fibrillation aggravated, painful respiration, thirst, malaise, chills, pyrexia and headache after administration of the suspect product Fluad. Chronology is plausible. Medical history of atrial fibrillation and epilepsy may have contributed to development of the events. Causality was also confounded by therapy with concomitant medication unspecified epilepsy medicine. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced atrial fibrillation aggravated, painful respiration, thirst, malaise, chills, pyrexia and headache after administration of the suspect product Fluad. Chronology is plausible. Medical history of atrial fibrillation and epilepsy may have contributed to development of the events. Causality was also confounded by therapy with concomitant medication unspecified epilepsy medicine. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as related.
poss SIDS; doubt very much that vax caused death but death occurred w/in 1 1/2 days p/vax; didn't feed well, wasn't acting normally & had noisy breathing; diaper had diarrheal stool & looked pale & not responding nl; metabolic acidosis;
Patient passed out 5 minutes after vaccine was administered. Epipen was administered and 911 called. Patient was conscious before the arrival of EMS. Per patient's mum , the patient has a history of passing out with needle stick. She sees it as a normal reaction.